Surgical end effectors with staple cartridges

ABSTRACT

An end effector for use with a surgical instrument includes an anvil with at least one staple pocket that defines a longitudinal axis. The staple pocket comprises a first cup and a second cup. The end effector also includes a staple cartridge.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 from U.S. patent application Ser. No. 13/776,803,entitled METHOD FOR FORMING A STAPLE, filed Feb. 26, 2013, which issuedon Nov. 20, 2018 as U.S. Pat. No. 10,130,359, which is acontinuation-in-part application claiming priority under 35 U.S.C. § 120from U.S. patent application Ser. No. 12/880,414, entitled SURGICALSTAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUETHEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME, filed Sep. 13,2010, now U.S. Patent Application Publication No. 2011/0060363, which isa continuation application claiming priority under 35 U.S.C. § 120 fromU.S. patent application Ser. No. 11/541,123, entitled SURGICAL STAPLESHAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME, filed Sep. 29, 2006, whichissued on Sep. 14, 2010 as U.S. Pat. No. 7,794,475, the entiredisclosures of which are hereby incorporated by reference herein.

This application is also a continuation application claiming priorityunder 35 U.S.C. § 120 from U.S. patent application Ser. No. 13/776,803,entitled METHOD FOR FORMING A STAPLE, filed Feb. 26, 2013, which issuedon Nov. 20, 2018 as U.S. Pat. No. 10,130,359, which is acontinuation-in-part application claiming priority under 35 U.S.C. § 120from U.S. patent application Ser. No. 12/622,130, entitled METHOD FORFORMING A STAPLE, filed Nov. 19, 2009, now U.S. Patent ApplicationPublication No. 2011/0087276, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/250,377, entitledSURGICAL STAPLER, filed Oct. 9, 2009, the entire disclosures of whichare hereby incorporated by reference herein.

The entire disclosures of the following commonly-owned, non-provisionalU.S. Patent Applications filed on Sep. 29, 2006 are hereby incorporatedby reference in their entirety:

(1) U.S. patent application Ser. No. 11/540,735, now U.S. Pat. No.7,467,740, entitled SURGICAL STAPLING INSTRUMENTS HAVING FLEXIBLECHANNEL AND ANVIL FEATURES FOR ADJUSTABLE STAPLE HEIGHTS;

(2) U.S. patent application Ser. No. 11/540,734, now U.S. Pat. No.7,472,815, entitled SURGICAL STAPLING INSTRUMENTS WITH COLLAPSIBLEFEATURES FOR CONTROLLING STAPLE HEIGHT;

(3) U.S. patent application Ser. No. 11/541,050, now U.S. Pat. No.8,360,297, entitled SURGICAL CUTTING AND STAPLING INSTRUMENT WITH SELFADJUSTING ANVIL;

(4) U.S. patent application Ser. No. 11/541,151, now U.S. Pat. No.7,665,647, entitled SURGICAL CUTTING AND STAPLING DEVICE WITH CLOSUREAPPARATUS FOR LIMITING MAXIMUM TISSUE COMPRESSION FORCE;

(5) U.S. patent application Ser. No. 11/541,164, now U.S. Pat. No.7,506,791, entitled SURGICAL STAPLING INSTRUMENT WITH MECHANICALMECHANISM FOR LIMITING MAXIMUM TISSUE COMPRESSION;

(6) U.S. patent application Ser. No. 11/529,904, now U.S. Pat. No.8,720,766, entitled SURGICAL STAPLING INSTRUMENTS AND STAPLES;

(7) U.S. patent application Ser. No. 11/541,374, now U.S. Pat. No.8,365,976, entitled SURGICAL STAPLES HAVING DISSOLVABLE, BIOABSORBABLEOR BIOFRAGMENTABLE PORTIONS AND STAPLING INSTRUMENTS FOR DEPLOYING THESAME;

(8) U.S. patent application Ser. No. 11/541,098, now U.S. Pat. No.8,220,690, entitled CONNECTED SURGICAL STAPLES AND STAPLING INSTRUMENTSFOR DEPLOYING THE SAME;

(9) U.S. patent application Ser. No. 11/529,935, now U.S. Pat. No.8,485,412, entitled SURGICAL STAPLES HAVING ATTACHED DRIVERS ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME;

(10) U.S. patent application Ser. No. 11/541,182, now U.S. PatentApplication Publication No. 2008/0078802, entitled SURGICAL STAPLES ANDSTAPLING INSTRUMENTS; and

(11) U.S. patent application Ser. No. 11/529,879, now U.S. Pat. No.8,348,131, entitled SURGICAL STAPLING INSTRUMENT WITH MECHANICALINDICATOR TO SHOW LEVELS OF TISSUE COMPRESSION.

The entire disclosures of the following commonly-owned, non-provisionalU.S. Patent Applications filed on Sep. 19, 2008 are hereby incorporatedby reference in their entirety:

(12) U.S. patent application Ser. No. 12/234,149, now U.S. Pat. No.7,905,381 entitled SURGICAL STAPLING INSTRUMENT WITH CUTTING MEMBERARRANGEMENT;

(13) U.S. patent application Ser. No. 12/234,133, now U.S. Pat. No.7,954,686, entitled SURGICAL STAPLER WITH APPARATUS FOR ADJUSTING STAPLEHEIGHT;

(14) U.S. patent application Ser. No. 12/234,113, now U.S. Pat. No.7,832,612, entitled LOCKOUT ARRANGEMENT FOR A SURGICAL STAPLER;

(15) U.S. patent application Ser. No. 12/234,143, now U.S. Pat. No.7,857,186, entitled SURGICAL STAPLER HAVING AN INTERMEDIATE CLOSINGPOSITION;

The entire disclosures of the following commonly-owned, non-provisionalU.S. Patent Applications filed on Nov. 19, 2009 are hereby incorporatedby reference in their entirety:

(16) U.S. patent application Ser. No. 12/622,099, now U.S. Pat. No.8,348,129, entitled SURGICAL STAPLER HAVING A CLOSURE MECHANISM; and

(17) U.S. patent application Ser. No. 12/622,113, now U.S. Pat. No.8,141,762, entitled SURGICAL STAPLER COMPRISING A STAPLE POCKET.

FIELD OF THE INVENTION

The present invention generally relates to endoscopic and open surgicalinstrumentation and, more particularly, to surgical staples and staplersincluding, but not limited to, open surgical stapling devices,laparoscopic surgical stapling devices, endoscopic and intralumenalsurgical stapling devices for producing one or more rows of staples.

BACKGROUND

Endoscopic and laparoscopic surgical instruments are often preferredover traditional open surgical devices since a smaller incision tends toreduce the post-operative recovery time and complications. The use oflaparoscopic and endoscopic surgical procedures has been relativelypopular and has provided additional incentive to develop the proceduresfurther. In laparoscopic procedures, surgery is performed in theinterior of the abdomen through a small incision. Similarly, inendoscopic procedures, surgery is performed in any hollow viscus of thebody through narrow endoscopic tubes inserted through small entrancewounds in the skin.

Laparoscopic and endoscopic procedures generally require that thesurgical region be insufflated. Accordingly, any instrumentationinserted into the body must be sealed to ensure that gases do not enteror exit the body through the incision. Moreover, laparoscopic andendoscopic procedures often require the surgeon to act on organs,tissues and/or vessels far removed from the incision. Thus, instrumentsused in such procedures are typically long and narrow while beingfunctionally controllable from a proximal end of the instrument.

Significant development has gone into a range of endoscopic surgicalinstruments that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

Known surgical staplers include an end effector that simultaneouslymakes a longitudinal incision in tissue and applies lines of staples onopposing sides of the incision. The end effector includes a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges which, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

Recently, an improved “E-beam” firing bar was described for a surgicalstapling and severing instrument that advantageously included a top pinthat slides within an internal slot formed in the upper jaw (anvil) andhas a middle pin and bottom foot that slides on opposite sides of alower jaw of an end effector, or more particularly a staple applyingassembly. Distal to the middle pin, a contacting surface actuates astaple cartridge held within an elongate staple channel that forms thelower jaw. Between the contacting surface and the top pin, a cuttingsurface, or knife, severs tissue clamped between the anvil and thestaple cartridge of the lower jaw. Since both jaws are thus engaged bythe E-beam, the E-beam maintains a desired spacing between the jaws toensure proper staple formation. Thus, if a lesser amount of tissue isclamped, the E-beam holds up the anvil to ensure sufficient spacing forthe staples to properly form against an undersurface of the anvil. Inaddition, if a greater amount of tissue is clamped, the E-beam drawsdown the anvil to ensure that the spacing does not exceed the length ofthe staple such that ends of each staple are not sufficiently bent toachieve a desired degree of retention. Such an E-beam firing bar isdescribed in U.S. patent application Ser. No. 10/443,617, entitledSURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM,filed on May 20, 2003, now U.S. Pat. No. 6,978,921, issued Dec. 27,2005, the disclosure of which is hereby incorporated by reference in itsentirety.

While an E-beam firing bar has many advantages for a surgical staplingand severing instrument, often it is desirable to sever and stapletissue of various thicknesses. A thin layer of tissue may result instaples that only form loosely, perhaps requiring the need forbolstering material. A thick layer of tissue may result in formedstaples that exert a strong compressive force on the captured tissue,perhaps resulting in necrosis, bleeding or poor stapleformation/retention. Rather than limiting the range of tissuethicknesses that are appropriate for a given surgical stapling andsevering instrument, it would be desirable to accommodate a wider rangeof tissue thickness with the same surgical stapling and severinginstrument.

Consequently, a significant need exists for an improved surgicalstapling and severing instrument that incorporates a staple applyingassembly (end effector) that adjusts to the amount of tissue that isclamped.

In addition, the staple drivers that are commonly employed in existingstaple applying assemblies are traditionally made as stiff as possibleto assure proper “B” form staple height. Because of this stiffconstruction, these drivers do not provide any flexibility for adjustingthe formed height of the staple to a particular thickness of tissueclamped within the assembly.

Thus, another significant need exists for staple drivers that are ableto facilitate the adjustment of the formed height of the staples inresponse to variations in tissue thickness.

In various types of endocutter arrangements, the anvil is opened andclosed by axially actuating a closure tube assembly that serves tointerface with closure features on the proximal end of the anvil. Theanvil is commonly formed with trunnions that are received in somewhatelongated slots in the proximal end of the channel. The trunnions serveto pivotally support the staple cartridge and permit the anvil to moveinto axial alignment while pivoting to a closed position. Unfortunately,however, this arrangement lacks means for limiting or adjusting theamount of clamping forces applied to the anvil during the clampingprocess. Thus, the same amount of clamping forces generated by theclosure tube assembly are applied to the anvil regardless of thethickness of the tissue to be clamped therein. Such arrangement canresult in thinner tissues being over clamped which could lead toexcessive bleeding and possibly damage or even destroy the tissue.

Thus, there is another need for a closure system that includes means forlimiting or adjusting the amount of closure forces applied to the anvilbased on the thickness of the tissue to be clamped between the anvil andthe staple cartridge.

In certain types of surgical procedures the use of surgical staples hasbecome the preferred method of joining tissue, and, specially configuredsurgical staplers have been developed for these applications. Forexample, intra-luminal or circular staplers have been developed for usein a surgical procedure known as an anastomosis. Circular staplersuseful to perform an anastomosis are disclosed, for example, in U.S.Pat. Nos. 5,104,025 and 5,309,927 which are each herein incorporated byreference.

An anastomosis is a surgical procedure wherein sections of intestine arejoined together after a connecting section has been excised. Theprocedure requires joining the ends of two tubular sections together toform a continuous tubular pathway. Previously, this surgical procedurewas a laborious and time consuming operation. The surgeon had toprecisely cut and align the ends of the intestine and maintain thealignment while joining the ends with numerous suture stitches. Thedevelopment of circular staplers has greatly simplified the anastomosisprocedure and also decreased the time required to perform ananastomosis.

In general, a conventional circular stapler typically consists of anelongated shaft having a proximal actuating mechanism and a distalstapling mechanism mounted to the shaft. The distal stapling mechanismtypically consists of a fixed stapling cartridge containing a pluralityof staples configured in a concentric circular array. A round cuttingknife is concentrically mounted in the cartridge interior to thestaples. The knife is moveable in an axial, distal direction. Extendingaxially from the center of the cartridge is a trocar shaft. The trocarshaft is moveable, axially, with respect to the cartridge and elongatedshaft. An anvil member is mounted to the trocar shaft. The anvil memberhas a conventional staple anvil mounted to it for forming the ends ofthe staples. The distance between the distal face of the staplecartridge and the staple anvil is controlled by an adjustment mechanismmounted to the proximal end of the stapler shaft. Tissue containedbetween the staple cartridge and the staple anvil is simultaneouslystapled and cut when the actuating mechanism is engaged by the surgeon.

When performing an anastomosis using a circular stapler, typically, theintestine is stapled using a conventional surgical stapler with doublerows of staples being emplaced on either side of a target section (i.e.,specimen) of intestine. The target section is typically simultaneouslycut as the section is stapled. Next, after removing the specimen, thesurgeon typically inserts the anvil into the proximal end of the lumen,proximal of the staple line. This is done by inserting the anvil headinto an entry port cut into the proximal lumen by the surgeon. Onoccasion, the anvil can be placed transanally, by placing the anvil headon the distal end of the stapler and inserting the instrument throughthe rectum. Typically the distal end of the stapler is insertedtransanally. The surgeon then ties the proximal end of the intestine tothe anvil shaft using a suture or other conventional tying device. Next,the surgeon cuts excess tissue adjacent to the tie and the surgeonattaches the anvil to the trocar shaft of the stapler. The surgeon thencloses the gap between the anvil and cartridge, thereby engaging theproximal and distal ends of the intestine in the gap. The surgeon nextactuates the stapler causing several rows of staples to be driventhrough both ends of the intestine and formed, thereby joining the endsand forming a tubular pathway. Simultaneously, as the staples are drivenand formed, a concentric circular blade is driven through the intestinaltissue ends, cutting the ends adjacent to the inner row of staples. Thesurgeon then withdraws the stapler from the intestine and theanastomosis is complete.

During the stapling process, however, the surgeon must be careful not toover compress the material that is being stapled to avoid killing ordetrimentally damaging that tissue. While some prior staplers are fittedwith an indicator mechanism for providing the surgeon with someindication of the spacing between the anvil and the staple cartridge, itis desirable for the stapler to include a mechanism that provides ameans for avoiding over compression of the tissue.

In recent years, there has been an increasing tendency for surgeons touse stapling instruments to suture body tissues such as a lung, anesophagus, a stomach, a duodenum and/or other organs in the intestinaltract. The use of an appropriate stapling instrument in many instancesmay perform a better job in less time and simplify previously difficultsurgical procedures such as gastrointestinal anastomoses. Previouslinear two and four row cutting staplers comprised cartridge-lessinstruments into which staples were individually hand-loaded. Otherprevious devices have included a presterilized disposable staple loadingunit and a cutting member which could be utilized for dividing thetissue and forming the rows of staples simultaneously. An example ofsuch a surgical stapler is disclosed in U.S. Pat. No. 3,499,591,entitled INSTRUMENT FOR PLACING LATERAL GASTROINTESTINAL ANASTOMOSES,which issued on Mar. 10, 1970, the entire disclosure of which is herebyincorporated by reference herein.

A stapling instrument can include a pair of cooperating elongate jawmembers, wherein each jaw member can be adapted to be inserted into aninternal, tubular body organ to be anastomosed. In various embodiments,one of the jaw members can support a staple cartridge with at least twolaterally spaced rows of staples, and the other jaw member can supportan anvil with staple-forming pockets aligned with the rows of staples inthe staple cartridge. Generally, the stapling instrument can furtherinclude a pusher bar and knife blade which are slidable relative to thejaw members to sequentially eject staples from the staple cartridge viacamming surfaces on the pusher bar. In at least one embodiment, thecamming surfaces can be configured to activate a plurality of stapledrivers carried by the cartridge and associated with the individualstaples to push the staples against the anvil and form laterally spacedrows of deformed staples in the tissue gripped between the jaw members.In typical stapling instruments, however, the anvil is unmovablerelative to the staple cartridge once the jaw members have beenassembled together and the formed height of the staples cannot beadjusted. In at least one embodiment, the knife blade can trail thepusher bar and cut the tissue along a line between the staple rows.Examples of such stapling instruments are disclosed in U.S. Pat. No.4,429,695, entitled SURGICAL INSTRUMENTS, which issued on Feb. 7, 1984,the entire disclosure of which is hereby incorporated by referenceherein.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 is a left side view in elevation of a surgical stapling andsevering instrument with an open end effector (staple applying assembly)with a shaft partially cut away to expose a firing member of a proximalfiring rod and distal firing bar guided by a frame ground andencompassed by a closure sleeve;

FIG. 2 is a left side view of a closed end effector (staple applyingassembly) with a retracted force adjusted height firing bar consistentwith the present invention of the surgical stapling and severinginstrument of FIG. 1 taken in longitudinal vertical cross section alonglines 2-2;

FIG. 3 is a left isometric view of the force adjusted (compliant) heightfiring bar of FIG. 2;

FIG. 4 is a left side view of a distal portion (“E-beam”) of a firstversion of the force adjusted height firing bar of FIG. 2 havinghorizontal slits formed respectively between the top pin and cuttingsurface and between the middle pin and the cutting surface to enhancevertical flexure;

FIG. 5 is a lower left isometric view of a distal portion (“E-beam”) ofa second version of the force adjusted firing bar of FIG. 2 having arelieved lower area of an upper pin to enhance vertical flexure;

FIG. 6 is a front view in elevation of an upper portion of the E-beam ofFIG. 5 taken in vertical and transverse cross section through the upperpin along lines 6-6;

FIG. 7 is a front view of an upper portion of a third version of theE-beam of FIG. 5 taken in vertical and transverse cross section alonglines 6-6 but further including relieved upper root attachments of thetop pin for enhanced vertical flexure;

FIG. 8 is a front view of an upper portion of a fourth version of theE-beam of FIG. 5 taken in vertical and transverse cross section alonglines 6-6 but including a resilient inner vertical laminate layerinstead of a relieved undersurface of the top pin for enhanced verticalflexure;

FIG. 9 is a front view of an upper portion of a fifth version of theE-beam of FIG. 5 taken in vertical and transverse cross section alonglines 6-6 but including an upper pin formed of a resilient materialinstead of a relieved undersurface of the upper pin for enhancedvertical flexure;

FIG. 10 is an upper left isometric view of a distal portion (“E-beam”)of a sixth version of the force adjusted firing bar of FIG. 2 havingresilient material upon a bottom foot to enhance vertical flexure;

FIG. 11 is a front view in elevation taken in vertical and transversecross section through the padded lower foot of the end effector (stapleapplying assembly) of the surgical stapling and severing instrument ofFIG. 1;

FIG. 12 is a left view in elevation of a distal portion (“E-beam”) of aseventh version of the force adjusted firing bar of FIG. 2 having aproximally and upwardly extended spring arm attached to a lower foot toenhance vertical flexure;

FIG. 13 is a left top isometric view of a distal portion (“E-beam”) ofan eighth version of the force adjusted firing bar of FIG. 2 having aspring washer encompassing a lower foot to enhance vertical flexure;

FIG. 14 is a cross-sectional end view of another staple applyingassembly or end effector of the present invention in a clamped or closedposition;

FIG. 15 is a partial perspective view of the staple applying assembly ofFIG. 14 with some of the elements thereof shown in cross-section;

FIG. 16 is a cross-sectional end view of another staple applyingassembly or end effector of the present invention in a clamped or closedposition;

FIG. 17 is a partial perspective view of the staple applying assembly ofFIG. 16 with some of the elements thereof shown in cross-section;

FIG. 18 is a partial perspective of a staple applying assembly of thepresent invention clamping a piece of tissue that has been partially cutand stapled;

FIG. 19 is a bottom view of an anvil embodiment of the presentinvention;

FIG. 20 is a longitudinal cross-sectional view of a staple applyingassembly employing the anvil embodiment depicted in FIG. 19;

FIG. 21 is a cross-sectional end view of the staple applying assembly ofFIG. 20 taken along line 21-21 in FIG. 20, with some elements shown insolid form for clarity;

FIG. 22 is another longitudinal cross-sectional view of the stapleapplying assembly of FIGS. 20 and 21 clamping a piece of tissue therein,wherein the tissue has varying cross-sectional thicknesses;

FIG. 23 is another partial longitudinal cross-sectional view of thestaple applying assembly of FIGS. 20-22 clamping another piece of tissuetherein;

FIG. 24 is another partial longitudinal cross-sectional of the stapleapplying assembly of FIGS. 20-23 clamping another piece of tissuetherein;

FIG. 25 is an end cross-sectional view of another staple applyingassembly of the present invention in a clamped position;

FIG. 26 is longitudinal cross-sectional view of another staple applyingassembly of the present invention;

FIG. 27 is a cross-sectional view of a portion of another stapleapplying assembly of the present invention with a piece of tissueclamped and stapled therein;

FIG. 28 is a top view of a portion of a biasing plate embodiment of thepresent invention;

FIG. 29 is a cross-sectional view of a portion of the biasing plate ofFIG. 28 taken along line 29-29 in FIG. 28;

FIG. 30 is an end cross-sectional view of the staple applying assemblyof FIG. 27 with some elements shown in solid form for clarity;

FIG. 30A is an end cross-sectional view of another staple applyingassembly of the present invention with some elements shown in solid formfor clarity;

FIG. 31 is a longitudinal cross-sectional view of the staple applyingassembly of FIGS. 27 and 30 with tissue clamped and stapled therein;

FIG. 32 is another longitudinal cross-sectional view of the stapleapplying assembly of FIG. 31 with another portion of tissue clamped andstapled therein;

FIG. 33 is another longitudinal cross-sectional view of the stapleapplying assembly of FIGS. 30-32 fluidically coupled to a fluidreservoir supported by a handle assembly of various embodiments of thepresent invention;

FIG. 34 is a longitudinal cross-sectional view of a staple applyingassembly of other embodiments of the present invention wherein tissue ofvarying thickness is clamped therein;

FIG. 35 is an enlarged cross-sectional view of a portion of the stapleapplying assembly of FIG. 34;

FIG. 36 is an exploded perspective view of a collapsible staple driverembodiment of the present invention in a first (uncollapsed) position;

FIG. 37 is a cross-sectional view of the collapsible staple driverembodiment of FIG. 36;

FIG. 38 is an exploded perspective view of another collapsible stapledriver embodiment of the present invention in a first (uncollapsed)position;

FIG. 39 is a cross-sectional view of the collapsible staple driverembodiment of FIG. 38;

FIG. 40 is a perspective view of another collapsible staple driverembodiment of the present invention;

FIG. 41 is an exploded perspective view of the collapsible staple driverembodiment of FIG. 40;

FIG. 42 is a cross-sectional view of the collapsible staple driverembodiment of FIGS. 40 and 41 in a first (uncollapsed) position;

FIG. 43 is another cross-sectional view of the collapsible staple driverembodiment of FIGS. 40-42 after compression forces have been appliedthereto;

FIG. 44 is an exploded perspective view of another collapsible stapledriver embodiment of the present invention;

FIG. 45 is a cross-sectional view of the collapsible staple driverembodiment of FIG. 44 in a first (uncollapsed) position;

FIG. 46 is an exploded perspective view of the collapsible staple driverembodiment of FIGS. 44 and 45 with some of the elements thereof shown incross-section;

FIG. 47 is an exploded front view of another collapsible staple driverembodiment of the present invention;

FIG. 48 is another front view of the collapsible staple driver of FIG.47 in a first (uncollapsed) position;

FIG. 49 is another front view of the staple driver of FIGS. 47 and 48after is has been compressed to a fully collapsed position;

FIG. 50 is an exploded assembly view of another collapsible stapledriver embodiment of the present invention;

FIG. 51 is an exploded front view of the collapsible staple driverembodiment of FIG. 50;

FIG. 52 is another front view of the collapsible staple driverembodiment of FIGS. 50 and 51 after being compressed into a fullycollapsed position;

FIG. 53 is a perspective view of another collapsible staple driverembodiment of the present invention;

FIG. 54 is a side elevational view of the collapsible staple driver ofFIG. 53 in a first (uncollapsed) position;

FIG. 55 is another side elevational view of the collapsible stapledriver of FIGS. 53 and 54 after being compressed to a fully collapsedposition;

FIG. 56 is a perspective view of a surgical cutting and stapleinstrument of various embodiments of the present invention;

FIG. 57 is an exploded assembly view of an end effector and elongateshaft assembly of various embodiments of the present invention;

FIG. 58 is an exploded assembly view of a handle assembly and closureshuttle arrangements of various embodiments of the present invention,with the firing system components omitted for clarity;

FIG. 59 is a cross-sectional side view of the handle assembly depictedin FIG. 58 with the closure trigger thereof in a locked position;

FIG. 60 is a left side exploded assembly view of a closure shuttle andclosure tube assembly of various embodiments of the present invention;

FIG. 61 is a right side exploded assembly view of a closure shuttle andclosure tube assembly of various embodiments of the present invention;

FIG. 62 is a partially enlarged view of a distal end of a closure tubeassembly interacting with a partially closed anvil with some of thecomponents shown in cross-section for clarity;

FIG. 63 is another partially enlarged view of the closure tube and anvilof FIG. 62 with the anvil illustrated in a fully closed position andsome elements shown in cross-section for clarity;

FIG. 64 is a partial perspective view of a closure tube assembly andanvil of various embodiments of the present invention;

FIG. 65 is a partial perspective view of another closure tube assemblyand anvil of various embodiments of the present invention;

FIG. 66 is a partial perspective view of another closure tube assemblyand anvil of various embodiments of the present invention with the anvilin a fully closed position;

FIG. 67 is cross-sectional end view of the closure tube and anvilarrangement of FIG. 66 with the elongate channel omitted for clarity;

FIG. 68 is a partially enlarged view of a closure tube and anvilarrangement of other various embodiments of the present invention withthe anvil in a partially closed position;

FIG. 69 is another partially enlarged view of the closure tube and anvilarrangement of FIG. 68 with the anvil in a fully closed position;

FIG. 70 is a cross-sectional view of another endocutter embodiment ofthe present invention with the anvil thereof in an open position andsome components shown in solid form for clarity;

FIG. 71 is another cross-sectional view of the endocutter embodiment ofFIG. 70 with the anvil in a fully closed position and some componentsshown in solid form for clarity;

FIG. 72 is an enlarged cross-sectional view of a portion of the anviland the closure tube assembly of the embodiments depicted in FIGS. 70and 71 with the anvil in its fully closed position;

FIG. 73 is another cross-sectional view of the endocutter embodiment ofFIG. 70 with the anvil in a maximum clamping position with somecomponents shown in solid form for clarity;

FIG. 74 is an enlarged cross-sectional view of a portion of the anviland the closure tube assembly of the embodiments depicted in FIG. 73with the anvil in its maximum clamping position;

FIG. 75 is an enlarged cross-sectional view of a portion of theendocutter depicted in FIGS. 70-74 clamping a thin piece of tissue;

FIG. 76 is another enlarged cross-sectional view of a portion of theendocutter depicted in FIGS. 70-75 clamping a thicker piece of tissue;

FIG. 77 is a perspective view of another stapling instrument of variousembodiments of the present invention;

FIG. 78 is an exploded perspective assembly view of an anvil and headarrangement that may be employed with various stapler embodiments of thetype depicted in FIG. 77;

FIG. 79 is an exploded perspective assembly view of a shaft and triggerassembly that may be employed with various embodiments of the staplerdepicted in FIG. 77;

FIG. 80 is a partial cross-sectional view of a shaft assembly and headassembly embodiment of the present invention with the anvil attached tothe shaft assembly;

FIG. 81 is a cross-sectional view of the handle assembly and closureknob assembly of various embodiments of the present invention;

FIG. 82 is a perspective view of the shaft assembly, trigger assembly,staple driver, anvil and closure knob assembly with the handle housing,head casing and outer tubular shroud removed therefrom;

FIG. 83 is a cross-sectional view of a knob assembly embodiment of thepresent invention;

FIG. 84 is a cross-sectional view of the knob assembly of FIG. 83 takenalong line 84-84 in FIG. 83;

FIG. 85 is a partial cross-sectional view of a stapler embodiment of thepresent invention inserted into separated portions of intestine;

FIG. 86 is another cross-sectional view of the staple and intestinearrangement of FIG. 85 with the proximal and distal ends of theintestine being sutured around the anvil shaft;

FIG. 87 is another cross-sectional view of the stapler and intestinearrangement of FIGS. 85 and 86 with the anvil retracted to a fullycompressed position and prior to firing the stapler;

FIG. 88 is another cross-sectional view of the stapler and intestinearrangement of FIGS. 85-87 after the staples have been fired and theknife has severed the portions of sutured intestine;

FIG. 89 is a perspective view of another stapler embodiment of thepresent invention;

FIG. 90 is partial cross-sectional view of a portion of the stapler ofFIG. 89;

FIG. 91 is cross-sectional view of a closure actuator that may beemployed with the stapler of FIGS. 89 and 90;

FIG. 92 is a cross-sectional view of the closure actuator of FIG. 91taken along line 92-92 in FIG. 91;

FIG. 93 is a cross-sectional view of a portion of the stapler of FIGS.89-92 inserted in a portion of an intestine with the stapler anvilretracted to a fully compressed position and prior to firing thestapler;

FIG. 94 is a graph illustrating the relationship between a compressionforce and resistive load generated by a variable force generator thatmay be used in connection with various embodiments of the presentinvention;

FIG. 95 is another view of the closure actuator of FIGS. 91 and 92;

FIG. 96 is a side view of a surgical staple in an undeployed shape inaccordance with an embodiment of the present invention;

FIG. 97 is a side view of the staple of FIG. 96 in a first deformedshape;

FIG. 98 is a side view of the staple of FIG. 96 in a second deformedshape;

FIG. 99 is a side view of the staple of FIG. 96 in a third deformedshape;

FIG. 100 is a top view of the staple of FIG. 99;

FIG. 101 is a perspective view of the staple of FIG. 96;

FIG. 102 is a perspective view of the staple of FIG. 97;

FIG. 103 is a perspective view of the staple of FIG. 98;

FIG. 104 is a perspective view of the staple of FIG. 99;

FIG. 105 is a partial cross-sectional view of a surgical stapler, andsurgical staples illustrated in various deformed shapes in accordancewith an embodiment of the present invention;

FIG. 106 is a side view of a surgical staple in accordance with analternative embodiment of the present invention;

FIG. 107 is a perspective view of the staple of FIG. 106;

FIG. 109 is a top view of the staple of FIG. 108;

FIG. 110 is a side view of the staple of FIG. 108 in a deformed shape;

FIG. 111 is a side view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 112 is a side view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 113 is a side view of a surgical staple in accordance with anembodiment of the present invention including a crushable member;

FIG. 114 is a side view of the staple of FIG. 113 in a deformed shape;

FIG. 115 is a side view of a surgical staple in accordance with anembodiment of the present invention including a spring having a firstelastic member and a second elastic member;

FIG. 116 is a top view of the staple of FIG. 115;

FIG. 117 is a side view of a surgical staple in accordance with anembodiment of the present invention including a cantilever spring;

FIG. 118 is a top view of the staple of FIG. 117;

FIG. 119 is a side view of a surgical staple in accordance with anembodiment of the present invention including a spring;

FIG. 120 is a side view of the staple of FIG. 119 in a deformed shape;

FIG. 121 is a top view of the staple of FIG. 120;

FIG. 122 is a perspective view of first and second deformable members ofa staple in accordance with an embodiment of the present invention;

FIG. 123 is a perspective view of a dissolvable, or bioabsorbable,material overmolded onto the deformable members of FIG. 122;

FIG. 124 is a perspective view of the staple of FIG. 123 in a deformedshape;

FIG. 125 is a perspective view of the staple of FIG. 124 where a portionof the dissolvable material has been dissolved and the first and seconddeformable members have moved relative to one another;

FIG. 126 is a perspective view of the staple of FIG. 125 after thedissolvable material has completely dissolved;

FIG. 127 is a partial cross-sectional view of a surgical stapler havingan anvil, and a staple cartridge for removably storing staples inaccordance with an embodiment of the present invention;

FIG. 128 is a partial cross-sectional view of the stapler of FIG. 127illustrating several staples in various deformed shapes;

FIG. 129 is a partial cross-sectional view of the stapler of FIG. 127taken along line 129-129 in FIG. 127;

FIG. 129A is a detail view of a staple in FIG. 129;

FIG. 130 is a detail view of the staple of FIG. 129A in a first deformedshape;

FIG. 131 is a detail view of the staple of FIG. 129A in a seconddeformed shape;

FIG. 132 is a side view of a staple in accordance with an alternativeembodiment of the present invention having two materials overmolded ontothe deformable members;

FIG. 133 is a detail view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 134 is a detail view of a staple in accordance with an alternativeembodiment of the present invention;

FIG. 135 is a perspective view of staples in accordance with anembodiment of the present invention;

FIG. 136 is a top view of a staple cartridge configured to accommodatethe staples of FIG. 135;

FIG. 137 is a detail view of the staple cartridge of FIG. 136;

FIG. 138 is a second detail view of the staple cartridge of FIG. 136;and

FIG. 139 is a cross-sectional view of the staple cartridge of FIG. 136having the staples of FIG. 135 therein;

FIG. 140 is a perspective view of staples and a staple cartridge of astapler in accordance with an embodiment of the present invention;

FIG. 141 is a detail view of the staple cartridge of FIG. 140;

FIG. 142 is a perspective view of a strip of the staples of FIG. 140;

FIG. 143 is a detail view of the staples of FIG. 142;

FIG. 144 is a side cross-sectional view of the staples and staplecartridge of FIG. 140;

FIG. 145 is a perspective view of a strip of staples in accordance withan alternative embodiment of the present invention;

FIG. 146 is a detail view of the staples of FIG. 145;

FIG. 147 is a side cross-sectional view of a stapler deploying thestaples of FIG. 145;

FIG. 148 is a perspective view of a strip of staples in accordance withan alternative embodiment of the present invention;

FIG. 149 is a detail view of the staples of FIG. 148;

FIG. 150 is a side cross-sectional view of a stapler deploying thestaples of FIG. 149;

FIG. 151 is a perspective view of a strip of staples in accordance withan alternative embodiment of the present invention;

FIG. 152 is a view of the staple strip of FIG. 151 stored within astaple cartridge;

FIG. 153 is a cross-sectional view of the staple cartridge of FIG. 152taken along line 153-153 in FIG. 152;

FIG. 154 is a cross-sectional view of the staple cartridge of FIG. 152taken along line 154-154 in FIG. 153;

FIG. 155 is a cross-sectional perspective view of the staple cartridgeof FIG. 152 with staples positioned in a first position;

FIG. 156 is a cross-sectional perspective view of the staple cartridgeof FIG. 152 with the staples positioned in a second position;

FIG. 157 is an additional cross-sectional perspective view of the staplecartridge of FIG. 152;

FIG. 158 is a perspective view of staples in accordance with anembodiment of the present invention connected in a “puck” configuration;

FIG. 159 is a bottom view of a staple cartridge in accordance with analternative embodiment of the present invention configured to receivethe staples of FIG. 158;

FIG. 159A is a detail view of the staple cartridge of FIG. 159;

FIG. 160 is a perspective of the staples of FIG. 158 positioned overdrivers of the staple cartridge of FIG. 159;

FIG. 161 is a perspective view of the drivers of FIG. 160;

FIG. 162 is a cross-sectional view of the staple cartridge of FIG. 159;

FIG. 163 is a second cross-sectional view of the staple cartridge ofFIG. 159;

FIG. 164 is a bottom view of a staple cartridge in accordance with analternative embodiment of the present invention;

FIG. 164A is a detail view of the staple cartridge of FIG. 164;

FIG. 165 is a perspective view of staples in accordance with analternative embodiment of the present invention;

FIG. 166 is a second perspective view of the staples of FIG. 165;

FIG. 167 is a cross-sectional view of the staples of FIG. 165 beingdeployed by a stapler in accordance with an embodiment of the presentinvention;

FIG. 168 is a perspective view of a staple assembly in accordance withan embodiment of the present invention;

FIG. 169 is a top view of the staple assembly of FIG. 168;

FIG. 170 is a perspective view of a staple cartridge configured toreceive the staple assembly of FIG. 169;

FIG. 171 is a top view of the staple cartridge of FIG. 170;

FIG. 172 is a cross-sectional view of the staples of FIG. 168 and thestaple cartridge of FIG. 170;

FIG. 173 is a perspective view of a staple assembly in accordance withan alternative embodiment of the present invention;

FIG. 174 is a perspective view of a staple assembly in accordance withan alternative embodiment of the present invention for formingnon-parallel staple patterns;

FIG. 175 is a top view of the staple of FIG. 174 positioned within astaple cartridge in accordance with an embodiment of the presentinvention;

FIG. 176 is a top view of staples and a staple cartridge in accordancewith an embodiment of the present invention;

FIG. 177 is a detail view of the staple cartridge of FIG. 176;

FIG. 178 is a cross-sectional view illustrating the shearable deck ofthe staple cartridge of FIG. 176;

FIG. 179 is a perspective view of a surgical stapling instrument inaccordance with at least one embodiment of the present invention;

FIG. 180 is an exploded perspective view of the surgical staplinginstrument of FIG. 179;

FIG. 181 is an exploded elevational view of the surgical staplinginstrument of FIG. 179;

FIG. 182 is a partial cross-sectional view of the surgical staplinginstrument of FIG. 179 illustrating first and second portions beingassembled together;

FIG. 183 is a partial cross-sectional view of the surgical staplinginstrument of FIG. 179 illustrating the proximal end of the firstportion of FIG. 182 being locked to the proximal end of the secondportion of FIG. 182 and illustrating the second portion being rotatedtoward the first portion;

FIG. 184 is a partial cross-sectional view of the surgical staplinginstrument of FIG. 179 illustrating a latch rotatably mounted to thefirst portion, wherein the latch is engaged with the second portion andwherein the latch has been rotated into a partially-closed position;

FIG. 185 is a partial cross-sectional view of the surgical staplinginstrument of FIG. 179 illustrating the latch of FIG. 184 in a closedposition;

FIG. 186 is a perspective view of a staple cartridge assembly of thesurgical stapling instrument of FIG. 179;

FIG. 187 is an exploded view of the staple cartridge assembly of FIG.186

FIG. 188 is a cross-sectional view of the staple cartridge assembly ofFIG. 186 taken along line 188-188 in FIG. 187;

FIG. 189 is an exploded view of a staple sled and cutting memberassembly of the staple cartridge assembly of FIG. 186;

FIG. 190 is a perspective view of the staple sled and cutting memberassembly of FIG. 189;

FIG. 191 is a perspective view of the surgical stapling instrument ofFIG. 179 illustrating a firing actuator moved distally along a firstside of the surgical stapling instrument;

FIG. 192 is a perspective view of the surgical stapling instrument ofFIG. 179 illustrating the firing actuator of FIG. 191 moved distallyalong a second side of the surgical stapling instrument;

FIG. 193 is a cross-sectional view of a surgical stapling instrument inaccordance with at least one alternative embodiment of the presentinvention illustrating a latch in a partially-closed position and alocking mechanism engaged with a firing actuator;

FIG. 194 is a cross-sectional view of the surgical stapling instrumentof FIG. 193 wherein the latch has been moved into a closed position andhas disengaged the locking mechanism from the firing actuator;

FIG. 195 is a perspective view of an anvil assembly of the surgicalstapling instrument of FIG. 179;

FIG. 196 is an exploded perspective view of the anvil assembly of FIG.195;

FIG. 197 is another exploded perspective view of the anvil assembly ofFIG. 195;

FIG. 198 is an exploded cross-sectional elevational view of the anvilassembly of FIG. 195;

FIG. 199 is a cross-sectional assembly view of the anvil assembly ofFIG. 195 illustrating an anvil adjustment member in a first position;

FIG. 200 is a cross-sectional assembly view of the anvil assembly ofFIG. 195 illustrating the anvil adjustment member of FIG. 199 in asecond position;

FIG. 201 is a cross-sectional assembly view of the anvil assembly ofFIG. 195 illustrating the anvil adjustment member of FIG. 199 in a thirdposition;

FIG. 202 is a perspective view of a surgical stapling instrument inaccordance with at least one alternative embodiment of the presentinvention;

FIG. 203 is a cross-sectional view of the surgical stapling instrumentof FIG. 202 taken along line 203-203 in FIG. 202;

FIG. 204 is a partial exploded view of the proximal end of the surgicalstapling instrument of FIG. 202 including a detent mechanism forreleasably holding a rotatable anvil adjustment member in position;

FIG. 205 is a perspective view of the surgical stapling instrument ofFIG. 202 with some components removed and others shown in cross-section;

FIG. 206 is an exploded view of portions of the surgical staplinginstrument of FIG. 202 illustrating a rotatable anvil adjustment memberin a first orientation;

FIG. 207 is a perspective view of the rotatable anvil adjustment memberof FIG. 206;

FIG. 208 is an end view of the surgical stapling instrument of FIG. 202with some components removed and others shown in dashed linesillustrating the rotatable anvil adjustment member in the firstorientation of FIG. 206;

FIG. 209 is a cross-sectional end view of the surgical staplinginstrument of FIG. 202 taken along line 209-209 in FIG. 202;

FIG. 210 is an end view of the surgical stapling instrument of FIG. 202illustrating the rotatable anvil adjustment member of FIG. 206 rotatedin a first direction into a second orientation;

FIG. 211 is a cross-sectional end view of the surgical staplinginstrument of FIG. 202 illustrating the anvil adjustment member in thesecond orientation of FIG. 210;

FIG. 212 is an end view of the surgical stapling instrument of FIG. 202illustrating the rotatable anvil adjustment member of FIG. 206 rotatedin a second direction into a third orientation;

FIG. 213 is a cross-sectional end view of the surgical staplinginstrument of FIG. 202 illustrating the anvil adjustment member in thethird orientation of FIG. 212;

FIG. 214 is a perspective view of an actuator for rotating the anviladjustment member of FIG. 206;

FIG. 215 is a partial cross-sectional view of a surgical staplinginstrument including a spring configured to bias the distal end of afirst handle portion away from the distal end of a second handle portionwhen the stapling instrument is in a partially-closed configuration;

FIG. 216 is a similar perspective view of the surgical staplinginstrument of FIG. 179 to that of FIG. 195;

FIG. 217 is a detail view of a latch projection extending from an anvilof a surgical stapling instrument in accordance with at least onealternative embodiment of the present invention;

FIG. 218 is a diagram illustrating the latch projection of FIG. 217 anda latch configured to engage the latch projection and move the latchprojection into a latch recess;

FIG. 219 is an elevational view of the latch projection of FIG. 217;

FIG. 220 is a perspective view of a staple pocket in accordance with atleast one embodiment of the present invention;

FIG. 221 is a top view of the staple pocket of FIG. 220;

FIG. 222 is a cross-sectional view of the staple pocket of FIG. 220taken along line 222-222 in FIG. 221;

FIG. 223 is a cross-sectional view of the staple pocket of FIG. 220taken along line 223-223 in FIG. 221;

FIG. 224 is another top view of the staple pocket of FIG. 220;

FIG. 225 is a cross-sectional view of the staple pocket of FIG. 220taken along line 225-225 in FIG. 224;

FIG. 226 is a cross-sectional view of the staple pocket of FIG. 220taken along line 226-226 in FIG. 224;

FIG. 227 is an elevational view of a surgical staple in an undeformedshape;

FIG. 228 is an elevational view of the surgical staple of FIG. 227 in adeformed shape in accordance with at least one embodiment of the presentinvention;

FIG. 229 is a side view of the surgical staple of FIG. 227 in thedeformed shape of FIG. 228;

FIG. 230 is a plan view of the surgical staple of FIG. 227 in thedeformed shape of FIG. 228;

FIG. 230A is another plan view of the surgical staple of FIG. 227 in thedeformed shape of FIG. 228;

FIG. 231 is an elevational view of a surgical staple in an undeformedshape;

FIG. 232 is a bottom view of the surgical staple of FIG. 231 in anundeformed shape;

FIG. 233 is a bottom view of the surgical staple of FIG. 231 in adeformed shape in accordance with at least one embodiment of the presentinvention;

FIG. 234 is a partial cross-sectional view of the surgical staple ofFIG. 231;

FIG. 235 is an elevational view of a surgical staple in a deformed shapein accordance with at least one embodiment of the present invention; and

FIG. 236 is an elevational view of a surgical staple in a deformedshape.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate preferred embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Turning to the Drawings, wherein like numerals denote like componentsthroughout the several views, in FIG. 1, a surgical stapling andsevering instrument 10 includes a handle portion 12 that is manipulatedto position an implement portion 14 including a fastening end effector,depicted as a staple applying assembly 16, distally attached to anelongate shaft 18. The implement portion 14 is sized for insertionthrough a cannula of a trocar (not shown) for an endoscopic orlaparoscopic surgical procedure with an upper jaw (anvil) 20 and a lowerjaw 22 of the staple applying assembly 16 closed by depression of aclosure trigger 24 toward a pistol grip 26 of the handle portion 12,which advances an outer closure sleeve 28 of the elongate shaft 18 topivot shut the anvil 20.

Once inserted into an insufflated body cavity or lumen, the surgeon mayrotate the implement portion 14 about its longitudinal axis by twistinga shaft rotation knob 30 that engages across a distal end of the handle12 and a proximal end of the elongate shaft 18. Thus positioned, theclosure trigger 24 may be released, opening the anvil 20 so that tissuemay be grasped and positioned. Once satisfied with the tissue held inthe staple applying assembly 16, the surgeon depresses the closuretrigger 24 until locked against the pistol grip 26, clamping tissueinside of the staple applying assembly 16.

Then a firing trigger 32 is depressed, drawn toward the closure trigger24 and pistol grip 26, thereby applying a firing force or motion theretoto distally advance a firing member from an unfired position. The firingmember is depicted as including a proximal firing rod 34 attached to adistal firing bar 36, that is supported within a frame ground 38 thatconnects the handle portion 12 to the staple applying assembly 16.During the staple firing motion, the firing bar 36 engages an elongatestaple channel 40 and actuates a staple cartridge 42 contained therein,both forming the lower jaw 22. The firing bar 36 also engages the closedanvil 20. After releasing the firing trigger 32 to apply a retractionforce or motion to the firing bar 36, depression of a closure releasebutton 44 unclamps the closure trigger 24 so that the closure sleeve 28may be retracted to pivot and open the anvil 20 to release the severedand stapled tissue from the staple applying assembly 16.

It should be appreciated that spatial terms such as vertical,horizontal, right, left etc., are given herein with reference to thefigures assuming that the longitudinal axis of the surgical instrument10 is co-axial to the central axis of the elongate shaft 18, with thetriggers 24, 32 extending downwardly at an acute angle from the bottomof the handle assembly 12. In actual practice, however, the surgicalinstrument 10 may be oriented at various angles and, as such, thesespatial terms are used relative to the surgical instrument 10 itself.Further, “proximal” is used to denote a perspective of a clinician whois behind the handle assembly 12 who places the implement portion 14distal, or away from him or herself. However, surgical instruments areused in many orientations and positions, and these terms are notintended to be limiting and absolute.

In FIG. 2, the staple applying assembly 16 is closed upon compressedtissue 46. In FIGS. 2-3, the firing bar 36 has a proximal portion 48that is attached to a distal E-beam 50 that translates within the stapleapplying assembly 16. As depicted with the firing bar 36 retracted, avertical portion 52 of the E-beam 50 resides essentially aft of thestaple cartridge 42, as after a new staple cartridge 42 has beeninserted into the elongate staple channel 40. An upper pin 54 thatextends laterally from an upper portion of the vertical portion 52 ofthe E-beam 50 initially resides within an anvil pocket 56 recessed neara proximal pivoting end of the anvil 20. As the E-beam 50 is distallyadvanced during the staple firing motion, the vertical portion 52 passesthrough a narrow longitudinal anvil slot 58 (FIGS. 1, 11) formed in astaple forming undersurface 60 of the anvil 20, a proximally openvertical slot 62 formed in cartridge 42 and an underlying longitudinalchannel slot 64 formed in the elongate staple channel 40.

In FIGS. 2, 11, the narrow longitudinal anvil slot 58 (FIG. 2)communicates upwardly to a laterally widened longitudinal anvil channel66 sized to slidingly receive the upper pin 54. The longitudinal channelslot 64 communicates downwardly to a laterally widened longitudinalchannel track 68 that receives a lower foot 70, which is sized to slidetherein and is attached at a bottom of the vertical portion 52 of theE-beam 50. A laterally widened middle pin 72 extending from the verticalportion 52 of the E-beam 50 is positioned to slide along a top surfaceof a bottom tray 74 of the staple cartridge 42, which in turn rests uponthe elongate staple channel 40. A longitudinal firing recess 75 formedin the staple cartridge 42 above the bottom tray 74 is sized to allowthe middle pin 72 to translate through the staple cartridge 42.

A distal driving surface 76 of the vertical portion 52 of the E-beam 50is positioned to translate through the proximally open vertical slot 62of the staple cartridge 42 and distally drive a wedge sled 78 proximallypositioned in the staple cartridge 42. The vertical portion 52 of theE-beam 50 includes a cutting surface 80 along a distal edge above thedistal driving surface 76 and below the upper pin 54 that severs theclamped tissue 46 simultaneously with this stapling.

With particular reference to FIG. 11, it should be appreciated that thewedge sled 78 drives upwardly staple drivers 82 that in turn driveupwardly staples 83 out of staple apertures 84 formed in a staple body85 of the staple cartridge 42 to form against the undersurface 60 of theanvil 20 which is in confronting relationship relative to an uppersurface 43 of staple cartridge 42 (FIG. 2).

In FIGS. 2, 11, advantageously, the illustrative spacing, denoted byarrow 86 (FIG. 2), between the upper pin 54 is compliantly biased towarda compressed state wherein 0.015 inches of compressed tissue 46 iscontained in the staple applying assembly 16. However, a larger amountof compressed tissue 46 up to about 0.025 inches is allowed by aninherent flexure of the E-beam 50. Excessive flexure, of perhaps up to0.030 inches, is avoided should the length of staples be insufficient toform with the additional height. It should be appreciated that thesedimensions are illustrative for a staple height of 0.036 inches. Thesame would be true for each category of staple, however.

In FIG. 4, a first version of a compliant E-beam 50 a includes top andbottom horizontal slits 90, 92 from a distal edge of the verticalportion 52 a, perhaps formed by electro drilling machine (EDM). Thevertical portion 52 a thus contains a vertically compliant top distallyprojecting arm 94 containing the upper pin 54, a knife flange 96containing the cutting surface 80, and a lower vertical portion 98containing the distal driving surface 76, middle pin 72 and lower foot70. The horizontal slits 90, 92 allow a compliant vertical spacing byallowing the top distally arm 94 to pivot upwardly to adjust toincreased force from compressed tissue 46 (not shown).

In FIGS. 5-6, a second version of a compliant E-beam 50 b includes leftand right lower relieved areas 110, 112 formed into an upper pin 54 b toeach side of the vertical portion 52, leaving left and right lowerbearing points 114, 116 respectively. The outboard position of thebearing points 114, 116 provides a long moment arm to exert the force toflex. It should be appreciated given the benefit of the presentdisclosure that the dimensions of the relieved areas 110, 112 and thechoice of materials for the compliant E-beam 50 b may be selected for adesired degree of flexure, given the staple size and otherconsiderations.

In FIG. 7, a third version of a compliant E-beam 50 c is as describedabove in FIGS. 5-6 with further flexure provided by left and right uppernarrow relieved areas 120, 122 formed into opposite top root surfaces ofan upper pin 54 c proximate to the vertical portion 52.

In FIG. 8, a fourth version of a compliant E-beam 50 d is as describedfor FIGS. 2-3 with an added feature of a composite/laminate verticalportion 52 d that includes a central resilient vertical layer 130sandwiched between left and right vertical layers 132, 134 that supportrespectively left and right portions 136, 138 of an upper pin 54 d. Asthe left and right portions 136, 138 are flexed either up or down, theresulting bowing of the left and right vertical layers 132, 134 areaccommodated by a corresponding compression or expansion of the centralresilient vertical layer 130.

In FIG. 9, a fifth version of a compliant E-beam 50 e is as describedfor FIGS. 2-3 with an added feature of a discrete upper pin 54 e formedof a more flexible material that is inserted through a horizontalaperture 140 through a vertical portion 52 e. Thus, left and right outerends 142, 144 of the discrete upper pin 54 e flex in accordance withloading forces.

Alternatively or in addition to incorporating flexure into an upper pin54, in FIGS. 10-11, a sixth version of a compliant E-beam 50 f asdescribed for FIGS. 2-3 further includes resilient pads 150 that areattached to upper surfaces 152 of the bottom foot 70. The resilient pads150 adjust the spacing of the upper pin 54 in accordance to thecompression force experienced at the bottom foot 70.

In FIG. 12, a seventh version of a compliant E-beam 50 g is as describedabove for FIGS. 2-3 with the added feature of a bottom foot (shoe) 70 ghaving an upwardly aft extended spring finger 160 that resiliently urgesthe E-beam 50 g downwardly to adjust vertical spacing in accordance withloading force.

In FIG. 13, an eighth version of a compliant E-beam 50 h is as describedabove in FIGS. 2-3 with the added feature of an oval spring washer 170resting upon the bottom foot 70 encircling the vertical portion 52 andhaving an upwardly bowed central portion 172 that resiliently urges theE-beam 50 h downwardly to adjust vertical spacing in accordance withloading force.

For another example, a compliant E-beam consistent with aspects of thepresent invention may include engagement to an anvil similar to theengagement in the illustrative versions of two structures that slideagainst opposite sides of the elongate staple channel. Similarly, acompliant E-beam may engage a lower jaw by having a laterally widenedportion that slides internally within a channel formed in a lower jawstructure.

As yet an additional example, in the illustrative version, the staplecartridge 42 is replaceable so that the other portions of the stapleapplying assembly 16 may be reused. It should be appreciated given thebenefit of the present disclosure that applications consistent with thepresent invention may include a larger disposable portion, such as adistal portion of an elongate shaft and the upper and lower jaws with astaple cartridge permanently engaged as part of the lower jaw.

As yet another example, the illustrative E-beam advantageouslyaffirmatively spaces the upper and lower jaws from each other. Thus, theE-beam has inwardly engaging surfaces that pull the jaws together duringfiring in instances where a larger amount of compressed tissue tends tospread the jaws. Thereby the E-beam prevents malformation of staples dueto exceeding their effective length. In addition, the E-beam hasoutwardly engaging surfaces that push the jaws apart during firing instances where a small amount of tissue or other structure attributes ofthe instrument tend to pinch the jaws together that may result in staplemalformation. Either or both functions may be enhanced by applicationsconsistent with aspects of the invention wherein inherent flexure in theE-beam adjusts to force to allow a degree of closing of the jaws or ofopening of the jaws.

FIG. 14 is an end cross-sectional view of a surgical instrument 10 athat has a staple applying assembly 16 a of another embodiment of thepresent invention wherein like reference numerals are used to designatelike elements and which employs an elongate channel 40 a for supportinga staple cartridge 42 therein. In various embodiments, the channel 40 ahas resilient or flexible features configured to enable the stapleapplying assembly 40 a to effectively accommodate different thicknessesof tissue. FIG. 15 is a partial perspective view of the staple applyingassembly 16 a with some components shown in cross-section for clarity.As can be seen in FIG. 14, in this embodiment, a first longitudinallyextending relief area 180 and a second longitudinally extending reliefarea 184 are provided in the longitudinal channel 40 a. The firstlongitudinally extending relief area 180 defines a first resilient orflexible channel ledge portion 182 and the second longitudinallyextending relief area 184 defines a second resilient or flexible channelledge portion 186. The elongate channel slot 64 through which the upperend 51 of the vertical portion 52 of the firing member in the form ofE-beam 50 extends is formed between the free ends 183, 185 of theflexible ledges 182, 186, respectively. As can be further seen in FIG.14, such arrangement permits the lower foot 70 of the E-beam 50 to bearupon the flexible ledge portions 182, 186 to accommodate differences inthe thickness of the tissue clamped between the anvil 20 and the lowerjaw 22 as the E-beam 50 transverses therethrough. It will be understoodthat the thickness 188 of the ledge portions 182, 186 may be selected toprovide the desired amount of flexure to those portions of the elongatechannel 40 a. Also, the choice of materials for the elongate channel 40a may be selected for a desired degree of flexure, in view of the staplesize and other considerations.

The elongate channel 40 a as described above may be used in connectionwith a staple applying assembly that employs a conventional anvil 20.That is, the longitudinally extending anvil slot 58 may essentially havea “T” shape that is sized to accommodate the upper pins 54 and an upperend 51 of the vertical portion 52 of the E-beam 50. The embodimentdepicted in FIGS. 14 and 15 employs and anvil 20 a that has resilient orflexible features for further accommodating differences in tissuethicknesses clamped between the anvil 20 a and the lower jaw 22. Inparticular, as can be seen in FIG. 14, a third longitudinally extendingrelief area 190 and a fourth longitudinally extending relief area 194may be provided in the anvil 20 a as shown. The third longitudinallyextending relief area 190 defines a first anvil ledge portion 192 andthe fourth longitudinally extending relief area 194 defines a secondanvil ledge portion 196 upon which the upper pins 54 of the E-beam 50may bear. Such arrangement provides a degree of flexure to the anvil 20a to accommodate differences in tissue thickness clamped between theanvil 20 a and the lower jaw 22. It will be understood that thethickness 198 of the ledge portions 192, 196 may be selected to providethe desired amount of flexure to those portions of the anvil 20 a. Also,the choice of materials for the anvil 20 a may be selected for a desireddegree of flexure, in view of the staple size and other considerations.Anvil 20 a may be used in connection with the above-described channelarrangement as shown in FIGS. 14 and 15 or it may be employed withconventional channel arrangements without departing from the spirit andscope of the present invention.

The person of ordinary skill in the art will also appreciate that theanvil 20 a and/or the channel 40 a may be successfully employed with aconventional E-beam arrangement or any of the E-beam arrangementsdepicted herein. The E-beams disclosed herein may be reciprocatinglydriven by control arrangements housed within the handle assembly.Examples of such control arrangements are disclosed in U.S. Pat. No.6,978,921, issued Dec. 27, 2005, which has been herein incorporated byreference. Other known firing member configurations and controlarrangements for applying firing and retraction forces or motionsthereto could conceivably be employed without departing from the spiritand scope of the present invention.

FIGS. 16 and 17 illustrate a staple applying assembly 16 b that employsanother version of a channel 40 b and an anvil 20 b that each haveresilient or flexible portions to accommodate differences in tissuethicknesses clamped between the anvil 20 b and the lower jaw 22 b. Ascan be seen in those Figures, a first pair 200 of upper and lowerlongitudinally extending relieved or undercut areas 202, 204 areprovided in the channel 40 b to define a first cantilever-type supportledge 206 and a second pair 210 of relieved or undercut areas 212, 214are provided in the channel 40 b to define a second cantilever-typesupport ledge 216. The first pair relieved areas 202, 204 provide adegree of flexure to the first support ledge 206 to enable it to flex asillustrated by arrow 205. Likewise, the second pair 210 of relievedareas 212, 214 provide a degree of flexure to the second support ledge216 to enable it to flex as illustrated by arrow 215. As with the abovedescribed embodiments, the thickness 208 of the support ledges 206 and216 may be selected to provide the desired amount of flexure to thoseportions of the elongate channel 40 b to accommodate differentthicknesses of tissue. Also, the choice of materials for the elongatechannel 40 b may be selected for a desired degree of flexure, in view ofthe staple size and other considerations.

FIGS. 16 and 17 further illustrate an anvil 20 b that has a T-shapedslot 58 b that defines a first lateral wall portion 220 and a secondlateral wall portion 222. In various embodiments, a first longitudinallyextending undercut area 224 is provided in the first lateral wallportion 220 to define a resilient or flexible first ledge 226.Similarly, in various embodiments, a second longitudinally extendingundercut area 228 is provided in the second lateral wall portion 222 todefine a resilient or flexible second ledge 230. As can be seen in FIG.16, the ends 227, 231 of the first and second ledges 226, 230,respectively serve to define a portion 59 b of anvil sot 58 b throughwhich an upper end portion 51 of E-beam 50 b extends. Such arrangementpermits the upper pins 54 b of the E-beam 50 b may bear upon the firstresilient ledge 226 and the second resilient ledge 230 to provide adegree of flexure to the anvil 20 ab to accommodate differences intissue thickness clamped between the anvil 20 b and the lower jaw 22 b.It will be understood that the thickness 232 of the ledges 226, 230 maybe selected to provide the anvil 20 b with a desired amount of flexureto accommodate different tissue thicknesses. Also, the choice ofmaterials for the anvil 20 b may be selected for a desired degree offlexure, in view of the staple size and other considerations. Anvil 20 bmay be used in connection with the above-described channel 40 b shown inFIGS. 16 and 17 or it may be employed with a conventional channelarrangement. The skilled artisan will also appreciate that the anvil 20a and/or the channel 40 bg may be successfully employed with aconventional E-beam arrangement or any of the E-beams described herein.

FIG. 18 illustrates the cutting and stapling of tissue 240 with any oneof the various surgical cutting and stapling instrument embodiments ofthe present invention. A portion 242 of the tissue 240 illustrated inFIG. 18 has already been cut and stapled. After the clinician has cutand stapled the first portion 242, the instrument would be withdrawn toenable new staple cartridge 42 to be installed. FIG. 18 illustrates theposition of the implement portion 14 prior to commencing the secondcutting and stapling process. As can be seen in that Figure, the portion242 of the tissue 240 that has been stapled has a thickness 243 that isless than the thickness 245 of other portions 244 of the tissue 240.

FIG. 19 is a view of the underside of an anvil 20 c that may be employedwith a staple applying assembly 16 c of various embodiments of thepresent invention. The anvil 20 c includes and anvil body 21 c thatsupports movable staple forming pockets that define different staplezones. In the embodiment depicted in FIG. 19, four left staple zones252, 254, 256, 258 are provided on a left side 250 of the anvil slot 58c and four right staple zones 262, 264, 266, 268 are provided on a rightside 260 of the anvil slot 58 c within the anvil body 21 c. The firstleft staple zone 252 is defined by a first left staple forming insertmember 270 that has a series of staple forming pockets 272 therein. Inthis embodiment, three rows 274, 276, 278 of staple forming pockets 272are provided in the insert 270. As can be seen in FIG. 19, the centralrow 276 of pockets 272 are slightly longitudinally offset from the outertwo rows 274, 278 of pockets 272 and correspond to the arrangement ofthe corresponding staple apertures 84 in corresponding staple cartridges42. Those of ordinary skill in the art will appreciate that sucharrangement serves to result in the application of the staples 83 in astaggered manner as illustrated in FIG. 18.

Similarly, the second left staple zone 254 may be defined by a secondleft staple forming insert 280 that may have three rows 282, 284, 286 ofstaple forming pockets 272 therein. The third left staple zone 256 maybe defined by a third left staple forming insert 290 that may have threerows 292, 294, 296 of staple forming pockets 272 therein. The fourthleft staple zone 258 may be defined by a fourth left staple forminginsert 300 that may have three rows 302, 304, 306 of staple formingpockets 272 therein. The first, second, third and fourth left stapleforming inserts 270, 280, 290, 300 are longitudinally aligned in a leftside cavity 251 provided in the anvil 20 c on the left side 250 of theanvil slot 58.

The first right staple zone 262 may be defined by a first right stapleforming insert member 310 that has a series of staple forming pockets272 therein. In this embodiment, three rows 312, 314, 316 of stapleforming pockets 272 are provided in the insert 310. As can be seen inFIG. 19, the central row 314 of staple forming pockets 272 are slightlylongitudinally offset from the outer two rows 312, 316 and correspond tothe arrangement of the corresponding staple apertures 84 incorresponding staple cartridges 42. Such arrangement serves to result inthe application of the staples 83 in a staggered manner on the rightside of the tissue cut line. The second right staple zone 264 may bedefined by a second right insert 320 that may have three rows 322, 324,326 of staple forming pockets 272 therein. The third right staple zone266 may be defined by a third right staple forming insert 330 that mayhave three rows 332, 334, 336 of staple forming pockets 272 therein. Thefourth right staple zone 268 may be defined by a fourth right stapleforming insert 340 that may have three rows 342, 344, 346 of stapleforming pockets 272 therein. The first, second, third, and fourth rightstaple forming inserts 310, 320, 33, 340 are longitudinally aligned in aright side cavity 261 provided in the anvil 20 c on the right side 260of the anvil slot 58. In various embodiments, the staple forming insertsmay be fabricated from stainless steel or other suitable materials thatare harder than the material from which the staples are fabricated. Forexample, the inserts may be successfully fabricated from other materialssuch as cobalt chromium, aluminum, 17-4 stainless steel, 300 seriesstainless steel, 400 series stainless steel, other precipitant hardenedstainless steels, etc.

At least one biasing member or compliant member in the form of a wavespring 350 or other suitable biasing or compliant medium or membercorresponding to each of the staple forming inserts 270, 280, 290, 300,310, 320, 330, 340 is provided between the respective left stapleforming inserts 270, 280, 290, 300 and the bottom of the left sidecavity 251 as shown in FIGS. 20-23. Wave springs 350 or other suitablebiasing or compliant medium or member is also provided between each ofthe right staple forming inserts 310, 320, 330, 340 and the bottomsurface of the right side cavity 261. The wave springs 350 on the leftside of the anvil slot 58 c may be received in a corresponding springcavity 253 and the wave springs 350 on the right side of the anvilcavity 58 c may be received in a corresponding spring cavity 263. Tobiasingly retain each insert 270, 280, 290, 300, 310, 320, 330, 340 inthe anvil 20 c, each insert 270, 280, 290, 300, 310, 320, 330, 340 maybe attached to its corresponding spring 350 or biasing member by, forexample, adhesive or other fastener arrangements. In addition, eachspring 350 may be attached to the anvil 20 c by, for example, adhesiveor other mechanical fastener arrangements to retain a portion of thewave spring 350 within its respective spring cavity 253 or 263. Suchspring/biasing member arrangements serve to bias the inserts 270, 280,290, 300, 310, 320, 330, 340 toward the tissue 240 and staples andessentially act as resilient “shock absorbers” to accommodatedifferences in tissue thicknesses. This advantage is illustrated inFIGS. 22-24.

In particular, as can be seen in FIG. 22, the portion 242 of the tissue240 clamped in the proximal end 17 b of the staple applying assembly 16c has a first thickness (arrow 243) that is thicker than the thickness(arrow 245) of the portion 244 of tissue 240 clamped in the centralportion 17 c of the staple applying assembly 16 c. The thickness 245 oftissue portion 244 is greater than the thickness (arrow 247) of theportion 246 of tissue 240 that is clamped in the distal end 17 a of thestaple applying assembly 16 c. Thus, the staples 83 formed in the distalportion 17 a of the staple applying assembly 16 c are more tightlyformed that the staples 83 formed in the central portion 17 c of thestaple applying assembly 16 c which are more tightly formed than thosestaples 83 formed in the proximal end 17 b of the staple applyingassembly 16 c due to the differences in tissue thicknesses. FIG. 23further illustrates the variations in staple formation heights basedupon the variations in the thicknesses of the tissue clamped within thestaple applying assembly 16 c. FIG. 24 illustrates a condition whereinthe tissue 240 clamped in the central portion 17 c of the stapleapplying assembly 16 c is thicker than the portions of tissue clamped inthe distal and proximal ends of the staple applying assembly 16 c. Thus,the formation heights of the staples in the central portion 17 c will behigher than the staple formation heights of the staples associated withthe proximal end 17 b and distal end 17 a of the staple applyingassembly 16 c.

Those of ordinary skill in the art will understand that the unique andnovel features of the embodiments depicted in FIGS. 19-24 may also beemployed in connection with a staple applying assembly that isessentially identical in construction and operation to staple applyingassembly 16 c described above, except that the staple forming inserts270, 280, 290, 300, 310, 320, 330, 340 may have just one row of stapleformation pockets 272 therein or two rows of staple formation pockets272 therein. For example, FIG. 25 illustrates an embodiment that onlyapplies two rows of staples on each side of the tissue cut line. Shownin that Figure are staple forming inserts 270 d and 310 d that only havetwo rows of staple forming pockets 272 d each.

The skilled artisan will further understand that the number of stapleforming inserts employed on each side of the anvil slot 58 may vary. Forexample a single longitudinally extending insert may be used on eachside of the anvil slot 58. FIG. 26 illustrates another staple applyingassembly 16 e of the present invention that only employs one stapleforming insert on each side of the anvil slot. FIG. 26 depicts across-sectional view of the left side of an anvil 20 e that supports asingle left staple forming insert 380 that is attached to a single wavespring 350 e. Other biasing members or multiple wave springs or biasingmembers may also be employed. The biasing member or members 350 e aresupported in the left side cavity 251 e and attached to the anvil 20 ein one of the various manners described above. A similar rights sideinsert (not shown) would be employed on the right side of the anvil slot58. Furthermore, although FIGS. 19-24 depict use of four staple forminginserts on each side of the anvil slot greater numbers of staple forminginserts may be employed.

FIGS. 27-29 illustrate another staple applying assembly 16 f of thepresent invention wherein a separate movable staple forming insert isprovided for each staple 83. In particular, as can be seen in FIG. 27, asingle staple forming insert 400 is provided for each staple 83. Eachstaple forming insert 400 may have staple forming pockets 404 formed onits underside 402 thereof for forming the ends of the correspondingstaple 83. As with various embodiment described above, each insert 400has a biasing member 412 associated therewith. In the example depictedin FIGS. 27-29, the biasing members 412 comprise stamped portions of abiasing plate 410. The biasing plate 410 may comprise a piece of metalor other suitable material wherein each biasing member 412 is stamped orotherwise cut and formed to correspond with a staple forming insert 400.The biasing plate 410 may comprise a single plate that is supportedwithin a cavity 251 f in the anvil 20 f or multiple plates 410 may beemployed on each side of the anvil slot. It will be understood that asimilar arrangement may be employed on the right side of the anvil sot.Each staple forming insert 400 may be attached to its correspondingbiasing member 412 by adhesive or other suitable fastener arrangement.Thus, it will be appreciated that a variety of different numbers andarrangements of movable staple forming inserts may be employed withoutdeparting from the spirit and scope of the present invention. Inparticular, at least one movable staple forming insert may be employedon each side of the anvil slot.

FIGS. 30-32 illustrate another staple applying assembly 16 g of otherembodiments of the present invention wherein the biasing or compliantmedium between the staple forming inserts and the anvil comprises atleast one fluid bladder. More specifically, as can be seen in FIG. 30, aleft bladder 420 is positioned within a left side cavity 253 g on theleft side of the anvil slot 58 g in the anvil 20 g. Likewise, a rightside bladder 430 is positioned with a right side cavity 263 in the anvil20 g. The series of left side staple forming inserts 270 g, 280 g, 290g, 300 g may be attached to the left side bladder 430 by a suitableadhesive or other fastener arrangement. Likewise the right side stapleforming inserts (not shown) may be attached to the right side bladder430 by adhesive or other suitable fastener arrangements. In oneembodiment, each bladder 420, 430 is sealed and partially filled with aliquid 432 such as, for example, glycerin oil or saline solution. Thoseof ordinary skill in the art will appreciate that such arrangement willpermit the staple forming inserts to move to better accommodatevariations in the thickness of the tissue clamped within the stapleapplying assembly 16 g. For example, for tissues that have a relativelyconstant thickness, the liquid 432 will be relatively evenly distributedwithin each of the bladders 420, 430 to provide a relatively evensupport arrangement for the staple forming inserts. See FIG. 31.However, when a thicker portion of tissue is encountered, those stapleforming inserts corresponding to the thicker tissue will be compressedinto their respective anvil cavity thereby forcing the liquid in thatpart of the bladder to the portions of the bladder corresponding to thethinner tissue portions. See FIG. 32.

In some applications, it may be desirable for the clinician to be ableto control the amount of pressure within the bladders 420, 430. Forexample, less pressure may be desirable when cutting and stapling moredelicate tissues such as lung tissue and the like. More pressure may bedesirable when cutting and stapling thicker tissues such as, forexample, stomach tissue, intestine tissue, kidney tissue, etc. Toprovide the clinician with this additional flexibility, the bladders420, 430 may each be fluidically coupled by a supply line 440 or conduitto a fluid reservoir 450 supported by the handle portion 12 of theinstrument. In the embodiment illustrated in FIG. 33, the clinician canincrease or decrease the amount of fluid within the bladders 420, 430and resulting pressure therein by means of an adjustment mechanism 460mounted to the fluid reservoir 450. In various embodiments, theadjustment mechanism 460 may comprise a piston 462 that is attached toan adjustment screw 464. By adjusting the adjustment screw 464 inward,the piston 462 forces fluid out of the reservoir 450 to the bladders420, 430. Conversely, by reversing the adjustment screw 464, the piston462 permits more fluid 432 to return or remain within the reservoir 450.To assist the clinician in determining the amount of pressure withinthat hydraulic system, generally designated as 405, a pressure gauge 470may be employed as shown. Thus, for those tissues requiring a higheramount of pressure, the clinician can preset the pressure in thebladders 420, 430 to a pressure that is conducive to successfully clampand staple that particular type of tissue. While a piston/screwarrangement has been described for controlling the pressure in thehydraulic system, the skilled artisan will understand that other controlmechanisms could successfully be employed without departing from thespirit and scope of the present invention.

FIG. 30A illustrates another staple applying assembly 16 hg of otherembodiments of the present invention wherein the biasing or compliantmedium between the staple forming inserts and the anvil comprises atleast one compressible polymer member. More specifically, as can be seenin FIG. 30A, a left compressible polymer member 420 h is positionedwithin a left side cavity 253 h on the left side of the anvil slot 58 hin the anvil 20 h. Likewise, a right side compressible polymer member430 h is positioned with a right side cavity 263 h in the anvil 20 h.The series of left side staple forming inserts 270 h-300 h may beattached to the left compressible polymer member 420 h by a suitableadhesive or other fastener arrangement. Likewise the right side stapleforming inserts 310 h-340 h may be attached to the right sidecompressible polymer member 430 h by adhesive or other suitable fastenerarrangements.

FIGS. 34-37 depict a unique and novel collapsible or compressible stapledriver arrangement that enables the various staple drivers toaccommodate different tissue thicknesses by collapsing or compressing inresponse to compression forces that the driver encounters during thefiring process. As used herein, the term “firing process” refers to theprocess of driving the staple drivers towards the staple formingundersurface of the anvil. As was mentioned above, prior staple driverswere fabricated from stiff/rigid material designed to resist deflectionand deformation when encountering compression forces during the firingprocess. A variety of such driver configurations are known. For example,some staple drivers are configured to support a single staple and othersare designed to support multiple staples. A discussion of single anddouble staple drivers and how they may be operably supported and firedwithin a staple cartridge is found in U.S. patent application Ser. No.11/216,562, filed Sep. 9, 2005, entitled STAPLE CARTRIDGES FOR FORMINGSTAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS, now U.S. Pat. No.7,669,746, the disclosure of which is herein incorporated by reference.

FIG. 34 depicts a staple applying assembly 16 h that includes anelongate channel 40 h that has an anvil 20 h pivotally coupled theretoin a known manner. The elongate channel 40 h is configured to operablysupport a staple cartridge 42 h therein. The anvil 20 h has a stapleforming undersurface 60 h thereon that is adapted to confront the uppersurface 43 h of the staple cartridge 42 h when the anvil 20 h is pivotedto the closed position shown in FIG. 34. The staples 83 are eachsupported on a corresponding staple driver 500, the construction ofwhich will be discussed in further detail below.

Each staple driver 500 may be movably supported within a correspondingstaple channel 87 h provided in the cartridge body 85 h as shown inFIGS. 34 and 35. Also operably supported within the cartridge body 85 his a driving member or wedge sled 78 that is oriented for engagement bythe E-beam firing member 50 during the firing process. See FIG. 34. Asthe E-beam firing member 50 and wedge sled 78 are driven distallythrough the elongate channel 40 h and staple cartridge 42 in a knownmanner, the wedge sled 78 drives the staple drivers 500 upwardly withinthe cartridge body 85 h. As the staple drivers 500 are driven upwardlytoward the staple forming undersurface 60 h of the anvil 20 h, theycarry with them their respective staple 83 or staples which are driveninto forming engagement with the corresponding staple forming pockets 61h in the staple forming undersurface 60 h of the anvil 20 h. As the ends88 of the staple 83 contact the forming pockets 61 h, they are bent overthus providing the staple 83 with a shape that somewhat resembles a “B”.While the various embodiments of the present invention have beendescribed herein in connection with E-beam firing members, it isconceivable that these various embodiments may also be successfullyemployed with a variety of different firing member and driving memberarrangements without departing from the spirit and scope of the presentinvention.

One collapsible staple driver embodiment of the present invention isdepicted in FIGS. 36 and 37. As can be seen in those Figures, thecollapsible or compressible staple driver 500 includes a base portion502 and a staple supporting portion 520 that is movable from a firstuncollapsed position relative to the base portion 502 in response tocompression forces generated during the firing process. In variousembodiments, the base portion 502 may have a forward support columnsegment 504 and a rearward support column segment 508 that is spacedfrom the forward support column segment 504 and is substantiallyintegrally formed therewith. The base portion 502 may also have anupstanding side portion 510 that has a rib 512 protruding from abackside therefrom. The upstanding side portion 510 serves to define areceiving ledge 514 in the base portion 502 for receiving the staplesupporting portion 520 thereon. Those of ordinary skill in the art willunderstand that when the staple supporting portion 520 is received onthe ledge 514, the staple driver 500 is unable to collapse or compressany further.

The staple supporting portion 520 of the staple driver 500 may similarlyinclude a forward support column segment 522 and rearward support columnsegment 524 that is spaced from the forward support column segment 522.When the staple supporting portion 520 is received on the base portion502, the forward support column segments 504, 522 serve to form aforward column portion 530 and the reward column segments 508, 524 forma rearward column portion 532. A forward staple receiving groove 526 isformed in the forward support column segment 522 and a rearward staplereceiving groove 528 is formed in the rearward support column segment524. The forward staple receiving groove 526 and the rearward staplereceiving groove 528 serve to support a staple 83 therein as illustratedin FIG. 35. The rib 512 and the forward column 530 and rearward column532 may cooperate with corresponding channels (not shown) in the staplecartridge body 85 to provide lateral support to the staple driver 500while permitting the driver to be driven upward within the cartridgebody 85 during the firing process.

In various embodiments, a resistive attachment structure, generallydesignated as 540′ is provided to support the staple supporting portion520 in a first uncompressed or uncollapsed orientation relative to thebase portion (FIG. 37) prior to encountering any compressive forcesduring the firing operation and to permit the staple supporting portion520 and the base portion to move towards each other (collapse orcompress) in response to the magnitude of the compression forces appliedto the staple supporting portion 520 and base portion 520 during thestaple firing operation. As can be seen in FIGS. 36 and 37, theresistive attachment structure 540′ in various embodiments may comprisea pair of attachment rods 540 that protrude from the bottom 521 of thestaple supporting portion 520 and correspond to holes or apertures 542in the base portion 502. The rods 540 are sized and shaped relative tothe holes 542 to establish an interference fit or “light press fit”(i.e., an interference of approximately 0.001 inches) therebetween suchthat when the staple supporting portion 520 and base driver portion 502are compressed together during the staple firing operation as will bediscussed in further detail below, the staple supporting portion 520 andthe base portion 502 can compress toward each other to reduce theoverall height of the staple driver 500 in relation to the amount ofcompression force encountered during the firing process. In variousembodiments, for example, the staple supporting portion 520 and baseportion 520 may be fabricated from the same material such as, forexample, plastic material such as ULTEM®. In other embodiments, the baseportion 502 and the staple supporting portion 520 may be fabricated fromdifferent materials. For example, staple supporting portion 520 may befabricated from ULTEM® and base portion 502 may be fabricated from glassor mineral filled ULTEM®. However, other materials could also beemployed. For example, the base portion 502 could be fabricated fromNylon 6/6 or Nylon 6/12.

In various embodiments, a frictional or an interference fit ofapproximately 0.001 inch may be established between the attachment rods540 and their corresponding holes 542. However, other degrees ofinterference fit may be employed to attain the desired amount and rateof driver compression in proportion to the magnitude of compressionforces encountered when stapling a particular type/thickness of tissue.For example, in one embodiment, the degree of interference fit betweenthe attachment rods 540 and their respective holes 542 may beapproximately 0.002 to 0.005 inches for stapling tissues wherein it isanticipated that compression forces on the order of 2-5 pounds may begenerated during the firing operation.

FIG. 35 illustrates various ranges of travel and compression that thestaple drivers 500 may experience when encountering tissues of varyingthicknesses. More specifically, FIG. 35 illustrates a portion of tissue560 clamped between the upper surface 43 h of the staple cartridge 42 hand the staple forming undersurface 60 h of the anvil 20 k Asillustrated in FIG. 35, the tissue 560 has three thicknesses. Thethickest portion of tissue is designated as 562 and comprises theportion of tissue that is on the right side of the Figure. The nextthickness portion of tissue is designated as 564 and the thinnestportion of tissue 560 is designated as 566 and is on the left side ofthe Figure. For the purposes of this explanation, the staple driverassociated with tissue portion 562 is designated as staple driver 500 a.The staple driver associated with tissue portion 564 is designated asstaple driver 500 b and the staple driver associated with tissue portion566 is designated as 500 c. It will be understood that staple drivers500 a, 500 b, 500 c, may be identical in construction to staple driver500 as described above.

Turning to staple driver 500 a first, as the staple driver 500 a isdriven upwardly towards the staple forming undersurface 60 h of theanvil 20 h by the wedge sled (not shown in FIG. 35), it encounters thethick tissue portion 562 which resists the upward movement of the stapledriver 500 a. Such resistive force (represented by arrow 570) opposesthe drive force (represented by arrow 572) generated by the wedge sledand serves to overcome the amount of interference established betweenthe attachment rods 540 and their respective holes 542 and forces therods 540 deeper into their respective holes 542 to thereby permit thestaple supporting portion 520 a of the staple driver 500 a and baseportion 502 a to move toward each other. This movement of the staplesupporting portion 520 a and base portion 502 a towards each other undera compressive force generated during the staple firing operation isreferred to herein as “collapsing” or “compressing”. When in thecompletely compressed position wherein the staple supporting portion 520a is received on the ledge 514 a of the base portion 502 a, the staplesupporting ledges 526 a, 528 a on the staple supporting portion 520 amay preferably support the bottom cross member 89 of the staple 83 abovethe upper surface 43 h of the staple cartridge 42 h to avoid catchingthe staple 83 on the staple cartridge 42 h when the staple applyingassembly 16 h is withdrawn. The compressed height of the staple driver500 a is designated by arrow 574 in FIG. 35.

Turning next to staple driver 500 b which corresponds to tissue portion564, because the tissue portion 564 is not as thick as tissue portion562, the resistive force 570 b encountered by the staple driver 500 bduring the firing operation is not as great as resistive force 570.Therefore, the attachment pins 540 b of staple driver 500 b are notadvanced into their respective holes 542 b as far as the pins 540 ofstaple driver 500 a were advanced into their respective holes 542. Thus,the compressed height 576 of staple driver 500 b is greater than thecompressed height 574 of staple driver 500 a. As can also be seen inFIG. 35, the bottom portion 89 of the staple 83 supported in stapledriver 500 b is supported above the upper surface 43 h of the staplecartridge 42 h.

Staple driver 500 c is associated with the thinnest tissue portion 566.Thus, the resistive force 570 c encountered by the staple driver 500 cduring the staple firing operation is less than the resistive force 570b that was encountered by staple driver 500 b. Thus, the pins 540 c ofstaple driver 500 c are not advanced into their respective holes 542 cas far as the pins 540 b of staple driver 500 b were advanced into theirrespective holes 542 b. Thus, the compressed height 578 of staple driver500 c is greater than the compressed height 576 of staple driver 500 b.

As can be further seen in FIG. 35, because the compressed height 578 ofstaple driver 500 c is greater than the compressed height 576 of stapledriver 500 b, the staple 83 c supported by staple driver 500 c wascompressed to a greater extent than the staple 83 b that was supportedby staple driver 500 b. Thus, the formed height of staple 83 c is lessthan the formed height of staple 83 b which is less than the formedheight of staple 83 a as illustrated in FIG. 35.

Those of ordinary skill in the art will appreciate that the number,shape, composition and size of the attachment rods and their respectiveholes can vary from embodiment to embodiment without departing from thespirit and scope of the present invention. Such interrelationshipbetween the attachment rods and their respective holes serves toestablish an amount of frictional interference therebetween which can beovercome in relation to various compression forces encountered whenclamping/stapling different thicknesses of tissue. In an alternativeversion, the attachment to rods 540 may be formed on the base portion502 and the holes provided in the staple supporting portion 520.

FIGS. 38 and 39 illustrate another staple driver 500 d embodiment of thepresent invention that may be substantially identical in constructionand operation to the staple drivers 500 described above, except that theattachment rods 540 d are somewhat tapered or frusto-conically shaped.In various embodiments, for example, the ends 541 d of the attachmentrods 540 d may be sized relative to holes 542 such that a light pressfit is established therebetween when in the first uncollapsed statedepicted in FIG. 39. The degree of taper of the attachment rods 540 dmay be tailored to attain the desired amount of staple drivercompression in relation to the magnitude of compression forcesencountered during the staple firing process. Thus, in theseembodiments, the magnitude of the interference fit between theattachment rods 540 d and the holes 542 increases as the staple driver500 d encounters greater compression forces which drive the attachmentrods 540 d deeper into their respective holes 542 d. In alternativeembodiments, the attachment rods 540 may have a round shape and theholes 542 may be tapered to attain the desired amount and rate of stapledriver compression in proportion to the amount of anticipatedcompression forces applied thereto during the firing operation. In analternative version, the attachment rods 540 d may be formed on the baseportion 502 and the holes 542 be formed in the staple supporting portion520.

FIGS. 40-43 illustrate another staple driver 500 e embodiment of thepresent invention that may be substantially identical in constructionand operation to the staple drivers 500 described above, except that theattachment rods 540 e are configured or shaped to include an additionalamount of material oriented to be sheared off of the remaining portionof the rods as the staple driver 500 e encounters compression forcesduring the firing operation. More specifically and with reference toFIG. 42, the attachment rods 540 e have a tip portion 541 e that isreceived within the corresponding hole 542 e. The tip portion 541 e maybe sized relative to the hole 542 e such that a sliding fit is achievedtherebetween or, in other embodiments, a small interference fit may beestablished between those components when in the first uncollapsedposition. The remaining portion 543 e of each attachment rod 540 e maybe provided or formed with an additional amount of material 545 e thatis designed to be sheared therefrom as the staple driver 500 eencounters the anticipated compression forces during the firingoperation. See FIG. 43. The additional material 545 e may extendcompletely around the circumference of the portion 543 e of eachattachment rod 540 e or the material 543 e may comprise one or moresegments oriented around the circumference of the attachment rod 540 e.For example, in the embodiment depicted in FIGS. 40-43, two segments 547e of material 543 e are diametrically opposed on each attachment rod 540e as shown. In various embodiments, the diametric distance between thesegments may be somewhat larger than the diameter of the holes 542 e tocause the segments 547 e to be sheared or removed from at least aportion of the rods 540 e as the staple driver 500 e encounters theanticipated compression forces during the firing operation.

The portions of additional material 543 e may comprise an integralportion of the attachment rod 540 e or the additional material 543 e maycomprise a second material applied to the attachment rod 540 e anddesigned to shear off therefrom when the staple driver 500 e encountersthe anticipated compression forces. In various embodiments, the baseportion 502 may be fabricated from a material that is more rigid thatthe material from which attachment rods 540 e and/or the additionalmaterial 543 e are fabricated such that the base portion 502 facilitatesthe shearing off of additional material 543 e as the staple supportportion 520 e and base portion 502 e are compressed together during thestaple firing operation. In an alternative version, the attachment rods540 e may be formed on the base portion 502 and the holes 542 e beprovided in the staple supporting portion 520 e.

FIGS. 44-46 illustrate another staple driver 500 f of the presentinvention that may be substantially identical in construction andoperation to the staple drivers 500 described above, except that theholes 542 f in the base portion 502 f may be hexagonally shaped or mayhave one or more surfaces therein designed to establish an interferencefit with the attached rods 540 or to otherwise resist further entry ofthe attachment rods 540 into the holes 542 f. For example, the holes 542f shown have a pair of flat surfaces 551 f formed therein that serve toestablish an interference fit or a degree of frictional resistancebetween the attachment rods 540 f and the holes 542 f which can beovercome by the various compression forces encountered whenclamping/stapling different thicknesses of tissue. In the embodimentdepicted in FIGS. 44-46, the attachment rods 540 have a substantiallycircular cross-sectional shape and the holes 542 f have flat surfaces551 formed therein. In alternative embodiments, however, the holes 542may be round and the flat surfaces may be formed on the attachment rods540. In an alternative version, the attachment rods 540 may be providedon the base portion 502 f and the holes 542 f be provided in the staplesupporting portion 520.

FIGS. 47-49 illustrate another staple driver 500 g of the presentinvention that comprises a base portion 502 g and a staple supportingportion 520 g. The staple supporting portion 520 g has staple supportinggrooves (not shown) formed therein and a downwardly protruding tang 580protruding from its undersurface 521 g. The tang 580 has two taperedsurfaces 582 and is shaped to be received in a corresponding cavity 590formed in the base portion 502 g. The cavity 590 is formed with taperedsides 592 and is sized to receive the tang 580 therein in the followingmanner. As the driver staple 500 g encounters the compression forcesgenerated during the firing operation, the tang 580 is forced into thecavity 590. FIG. 49 illustrates the staple driver 500 g in a fullycollapsed or compressed position. The staple supporting portion 520 gand/or tang 580 may be fabricated from a material that is somewhat morecompliant than the material from which the base portion 502 g is formedso that the tang 580 can be forced into the cavity 590 in the baseportion 502 g without substantially distorting the base portion 502 g tothe extent that it would hamper the ability of the staple driver 500 gto be fully driven to a final firing position. For example, the staplesupporting portion and/or the tang 580 may be fabricated from ULTEM® andthe base portion 502 g may be fabricated from glass filled Nylon toachieve the desired amount of driver compression when encountering theanticipated compression forces during the firing operation. In analternative version, the tang 580 may be provided on the base portion502 g and the hole 590 be provided in the staple supporting portion 520g.

FIGS. 50-52 illustrate another staple driver 500 h embodiment of thepresent invention that may be substantially identical in constructionand operation to the staple drivers 500 described above, except that,instead of attachment rods, the staple supporting portion 520 h has twotapered tangs 600 protruding therefrom designed to be compressed into aV-shaped cavity 610 formed in the base portion 502 h. Prior tocommencement of the firing operation, the staple supporting portion 520h is supported on the base portion 502 h within the staple cartridge. Asthe staple supporting portion 520 h and the base portion 502 h arecompressed together during the firing operation, the tapered tangs 600are forced inwardly as shown in FIG. 52. The degree to which the tangs600 are compressed into the V-shaped cavity 610 is dependent upon themagnitude of the compression forces encountered during the firingoperation.

The staple supporting portion 500 h and/or tangs 600 may be fabricatedfrom a material that is somewhat more compliant than the material fromwhich the base portion 502 h is formed so that the tangs 560 can beforced into the V-shaped cavity 610 in the base portion 502 h withoutsubstantially distorting the base portion 502 h to the extent that itwould hamper the ability of the staple driver 500 h to be fully drivento a final firing position. For example, the staple supporting portionand/or the tangs 600 may be fabricated from Nylon with no fill and thebase portion 502 h may be fabricated from ULTEM® with a glass or mineralfill to achieve the desired amount of staple driver compression whenencountering the anticipated compression forces during the firingoperation. In an alternative version, the tangs 600 may be provided onthe base portion 502 h and the cavity 610 may be provided in the staplesupporting portion 520 h.

FIGS. 53-55 illustrate yet another staple driver 500 i embodiment of thepresent invention that includes a staple supporting portion 520 i thathas V-shaped staple supporting grooves 630 i, 650 i therein. In thisembodiment, the staple supporting portion 520 i has a first pair 620 iof two tapered tangs 622 i, 626 i protruding therefrom oriented to becompressed into the first V-shaped groove or cavity 630 i and a secondpair 640 i of two tapered tangs 642 i, 646 i oriented to be compressedinto the second V-shaped groove or cavity 650 i. More specifically andwith reference to FIG. 54, the first tang 622 i has an end 624 i that isspaced from an end 628 i of the second tang 626 i prior to commencementof the staple firing operation. When in the position illustrated in FIG.54, the ends 624 i, 628 i are biased outwardly into frictional contactwith the upper side walls of the first V-shaped groove 630 i to retainthe staple supporting portion 520 i in the uncollapsed position shown inFIG. 54. Although not shown, the second pair 640 i of tangs 642 i, 646 iare also similarly configured as tangs 622 i, 626 i and serve to engagethe second V-shaped groove 650 i in the same manner.

As the staple supporting portion 520 i and the base portion 502 i arecompressed together during the firing operation, the ends 624 i, 628 iof the first tangs 622 i, 626 i and the ends of the second tangs 642 i,646 i are biased toward each other to permit the tangs to be drivendeeper into their respective grooves 630 i, 650 i. FIG. 55 illustratesthe first pair 620 i of tangs 622 i, 626 i in their fully compressedstate which also corresponds to the fully compressed state of the driver500 i. The degree to which the tangs are compressed into theirrespective V-shaped grooves is dependent upon the magnitude of thecompression forces encountered during the firing operation.

The staple supporting portion 500 i and/or tangs 622 i, 626 i, 642 i,646 i may be fabricated from a material that is somewhat more compliantthan the material from which the base portion 502 i is formed so thatthe tangs 622 i, 626 i, 642 i, 646 i can be forced into their respectiveV-shaped grooves in the base portion 502 i without substantiallydistorting the base portion 502 i to the extent that it would hamper theability of the driver 500 i to be fully driven to a final firingposition. For example, the staple supporting portion 520 i and/or thetangs 622 i, 626 i, 642 i, 646 i may be fabricated from ULTEM® and thebase portion 502 i may be fabricated from Nylon with a glass or mineralfill to achieve the desired amount of driver compression whenencountering the anticipated compression forces during the firingoperation. In an alternative version, the tangs 622 i, 626 i, 642 i, 646i may be provided on the base portion 502 i and the V-shaped grooves 630i, 650 i may be provided in the staple supporting portion 520 i.

The various embodiments of the present invention described above andtheir respective equivalent structures represent vast improvements overprior staple applying assemblies and end effectors. Various embodimentsof the present invention provide anvils and/or channels with flexibleportions that permit the overall staple height to increase as thecompression within the assembly increases due to tissue thickness. Otherembodiments employ anvil arrangements that have flexible forming pocketsthat can be compressed away from the staple cartridge in response tovariations in tissue thickness. In doing so, the inherent gap betweenthe forming pocket and the cartridge increases which serves to increasethe formed height of the staple. Such advantages can result in improvedstaple line consistency and provide better clinical outcomes.

FIGS. 56-63 illustrate another surgical stapling and severing instrument1000 of the present invention. As can be seen in FIG. 56, the instrument1000 includes a handle assembly 1020 that is manipulated to position animplement portion 1014 including a fastening end effector, depicted as astaple applying assembly 1016, distally attached to an elongate shaftassembly 1100. The implement portion 1014 is sized for insertion througha cannula of a trocar (not shown) for an endoscopic or laparoscopicsurgical procedure with an upper jaw (anvil) 1050 and a lower jaw 1018of the staple applying assembly 1016 closed by depression of a closuretrigger 1040 toward a pistol grip 1034 of the handle assembly 1020,which advances an outer closure tube assembly 1130 of the elongate shaftassembly 1100 to pivot the anvil 1050 to a closed position as will bediscussed in further detail below.

Once inserted into an insufflated body cavity or lumen, the closuretrigger 1040 may be released, opening the anvil 1050 so that tissue maybe grasped and positioned. Once satisfied with the tissue held in thestaple applying assembly 1016, the surgeon depresses the closure trigger1040 until locked against the pistol grip 1034, clamping tissue insideof the staple applying assembly 1016. Then a firing trigger 1046 isdrawn toward the closure trigger 1040 and pistol grip 1034, therebyapplying a firing force or motion thereto to distally advance a firingmember supported with in the implement 1014 from an unfired position. Asthe firing member advances through the implement or end effector 1014 ina known manner, it severs the tissue clamped within the end effector1014 and fires or drives the staples contained with the staple cartridge42 supported therein.

As depicted in FIG. 57, this embodiment may employ the firing bar 36 andE-Beam 50 arrangements described above. In other alternativeembodiments, the E-Beam arrangements described in U.S. patentapplication Ser. No. 11/231,456, filed Sep. 21, 2005 and entitledSURGICAL STAPLING INSTRUMENT HAVING FORCE CONTROLLED SPACING ENDEFFECTOR, now U.S. Pat. No. 7,407,078, the disclosure of which is hereinincorporated by reference may also be employed. In addition, as thepresent Detailed Description proceeds, those of ordinary skill in theart will appreciate that the advantages provided by these embodiments ofthe present invention may be effectively attained when used inconnection with other known non-E beam firing bar configurations. Thus,these embodiments of the present invention should not be limited solelyto use in connection with E-beam type firing and cutting arrangements.

FIG. 57 depicts the firing bar 36 as including a proximal firing rod 34,that is supported within a “frame ground” or spine assembly 1110 thatconnects the handle assembly 1020 to the staple applying assembly 1016.During the staple firing motion, the firing bar 36 engages an elongatestaple channel 1060 and actuates a staple cartridge 42 containedtherein, both forming the lower jaw 1018 in the various mannersdescribed above.

A variety of different firing arrangements for applying an actuationforce to the firing bar 36 to cause the firing bar to linearly advanceand retract through the staple applying assembly 1016 are known. Suchfiring motions may be manually generated such as through use of thevarious firing system arrangements disclosed in U.S. patent applicationSer. No. 11/475,412, filed Jun. 27, 2006, entitled MANUALLY DRIVENSURGICAL CUTTING AND FASTENING INSTRUMENT, now U.S. Pat. No. 8,322,455,the disclosure of which is herein incorporated by reference. Still otheractuation systems, such as the pneumatically powered actuation systemsdisclosed in U.S. patent application Ser. No. 11/497,898, filed Aug. 2,2006, entitled PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH A VARIABLE CONTROL OF THE ACTUATING RATE OF FIRING WITHMECHANICAL POWER ASSIST, now U.S. Pat. No. 7,740,159, the disclosure ofwhich is herein incorporated by reference may be successfully employed.Other embodiments may include, for example, the electrical motor drivenactuation systems disclosed in U.S. patent application Ser. No.11/343,562, filed Jan. 31, 2006, entitled MOTOR-DRIVEN SURGICAL CUTTINGAND FASTENING INSTRUMENT WITH ARTICULATABLE END EFFECTOR, now U.S. Pat.No. 7,568,603, the disclosure of which is also herein incorporated byreference. Still other embodiments may include other known mechanically,electrically, hydraulically and/or pneumatically powered firing systemswithout departing from the spirit and scope of the present invention.

In various embodiments, the elongate shaft assembly 1100 consists of aclosure tube assembly 1130 that is received on the spine assembly 1110.See FIG. 57. The spine assembly 1110 may comprise a single member or itmay comprise multiple segments with an articulation joint (not shown)mounted therein. Such articulation joints are known in the art and may,for example, be mechanically, electrically, hydraulically orpneumatically controlled. In the embodiment depicted in FIGS. 57 and 58,the spine assembly 1110 includes a proximal portion 1112 (FIG. 58) and adistal portion 1116 (FIG. 57). As will be discussed below, the proximalportion 1112 is attached to the handle assembly 1020 such that theclosure tube assembly 1130 may be axially moved thereon to cause theanvil 1050 to pivot between open and closed positions. As can be seen inFIG. 57, the elongate channel 1060 has proximally placed attachmentcavities 1062 that each receive a corresponding channel anchoring member1118 formed on the distal end of the distal spine portion 1116. Theelongate channel 1060 also has elongated anvil cam slots 1064 thatmovably receive a corresponding anvil trunnion 1052 on the anvil 1050 aswill be discussed in further detail below.

The closure tube assembly 1130 may comprise a distal closure tubeportion 1140 and a proximal closure tube portion 1150. The distalclosure tube portion 1140 and the proximal closure tube portion 1150 maybe fabricated from a polymer or other suitable material. The distalclosure tube portion 1140 and the proximal closure tube portion 1150 areeach hollow for receiving a corresponding portion of the spine assembly1110 therein. The closure tube assembly 1130 is depicted as comprisingtwo separate portions 1140 and 1150 for ease of assembly of the entireelongate shaft assembly 1100. Those portions 1140 and 1150 may beattached together after assembly by adhesive or other suitable fasteningmeans. It is conceivable, however, that the closure tube assembly 1130may be fabricated as one piece. In addition, as was mentioned above, thespine assembly of various embodiments of the present invention may havean articulation joint mounted therein. For those embodiments, a doublepivot closure joint (not shown) may be employed in the closure tubeassembly 1130. Examples of such double pivot closure arrangements aredisclosed in U.S. patent application Ser. No. 11/497,898, now U.S. Pat.No. 7,740,159, which has been herein incorporated by reference.

In use, the closure tube assembly 1130 is translated distally to closethe anvil 1050, for example, in response to the actuation of the closuretrigger 1040. The anvil 1050 is closed by distally translating theclosure tube assembly 1130 on the spine assembly 1110, causing the backof a horseshoe aperture 1142 in the distal closure tube portion 1140 tostrike a closure feature 1053 in the form of an open/closing tab 1052 onthe anvil 1050 and cause it to pivot to the closed position. See FIG.57. To open the anvil 1050, the closure tube assembly 1130 is axiallymoved in the proximal direction on the spine assembly 1110 causing a tab1144 on the distal closure tube portion 1140 to contact and push againstthe open/closing tab 1054 on the anvil 1050 to pivot the anvil 1050 tothe opened position.

FIG. 58 illustrates an exploded assembly view of a non-limiting handleassembly 1020 of various embodiments of the present invention whereinthe various firing system components have been omitted for clarity. Inthe embodiment depicted in FIG. 58, the handle assembly 1020 has a“pistol grip” configuration and is formed from a right hand case member1022 and a left handed case member 1028 that are molded or otherwisefabricated from a polymer or other suitable material and are designed tomate together. Such case members 1022 and 1028 may be attached togetherby snap features, pegs and sockets molded or otherwise formed thereinand/or by adhesive, screws, bolts, clips, etc. The upper portion 1024 ofthe right hand case member 1022 mates with a corresponding upper portion1030 of the left hand case member 1028 to form a primary housing portiondesignated as 1031. Similarly, the lower grip portion 1025 of the righthand case member 1022 mates with the lower grip portion 1032 of the lefthand case member 1028 to form a grip portion generally designated as1034. See FIG. 56. Those of ordinary skill in the art will readilyappreciate, however, that the handle assembly 1020 may be provided in avariety of different shapes and sizes.

For the purposes of clarity, FIG. 58 only illustrates the componentsemployed to control the axial movement of the closure tube assembly 1130which ultimately controls the opening and closing of the anvil 1050. Ascan be seen in that Figure, a closure shuttle 1160 that is coupled tothe closure trigger 1040 by a linkage assembly 1180 is supported withinthe primary housing portion 1031. Closure shuttle 1160 may also befabricated in two pieces 1162, 1164 that are molded or otherwisefabricated from a polymer or other suitable material and are designed tomate together. For example, in the embodiment illustrated in FIGS. 58,60, and 61, the right hand portion 1162 may be provided with fastenerposts 1163 that are designed to be received within corresponding sockets1167 (FIG. 61) in the left hand portion 1164. The right and left handportions 1162, 1164 may be otherwise retained together by snap membersand/or adhesive and/or bolts, screws, clips, etc. As can be seen inthose Figures, a retention groove 1152 is provided in the proximal end1151 of the proximal closure tube portion 1150. The right hand portion1162 of the closure shuttle 1160 has a right retention flange 1165 (FIG.60) that is adapted to cooperate with a left hand portion 1164 of theclosure shuttle 1160 such that the retention flange 1165 extends intothe retention groove 1151 in the proximal closure tube portion 1150. Theretention flange 1165 serves to affix the closure tube assembly 1130 tothe closure shuttle 1160 while facilitating its limited axial movementrelative thereto as will be discussed in further detail below.

As can also be seen in FIG. 58, a right spine assembly retention peg1027 protrudes inward from the right hand case member 1024. Such peg1027 protrudes into an elongated slot or window 1166 in the right handportion 1162 of the closure shuttle 1160. A similar closure shuttleretention peg (not shown) protrudes inward from the left hand casemember 1164 to be received in another window or slot 1168 provided inthe left hand side portion 1164 of the closure shuttle 1160. Theretention pegs are configured to extend into a hole 1115 in the proximalend 1114 of the proximal spine portion 1110 to non-movably affix thespine portion 1110 to the handle assembly 1020 while permitting theclosure shuttle 1160 to move axially relative thereto. See FIG. 58. Theretention pegs may be mechanically attached to the proximal end 1114 ofthe proximal spine portion 1112 by, for example, bolts, screws,adhesive, snap features, etc. In addition, the closure shuttle 1160 isprovided with laterally extending guide rails 1170, 1172. Rail 1170 isconfigured to be slidably received within rail guide 1026 in the righthand case member 1024 and rail 1172 is configured to be slidablyreceived within a rail guide (not shown) in left hand case member 1028.See FIG. 58.

Axial movement of the closure shuttle 1160 and closure tube assembly1130 in the distal direction (arrow “A”) is created by moving theclosure trigger 1040 toward the grip portion 1034 of the handle assembly1020 and axial movement of the closure shuttle 1160 in the proximaldirection (arrow “B”) is created by moving the closure trigger 1040 awayfrom the grip portion 1034. In various embodiments, the closure shuttle1160 is provided with a connector tab 1174 that facilitates theattachment of the closure linkage assembly 1180 thereto. See FIGS. 58and 59. The closure linkage assembly 1180 includes a yoke portion 1182that is pivotally pinned to the connector tab 1174 by a pin 1184. Theclosure linkage assembly 1180 further has a closure arm 1186 that ispivotally pinned to a yoke assembly 1043 formed on the closure trigger1042 by a closure pin 1188 as illustrated in FIG. 58. The closuretrigger 1140 is pivotally mounted within the handle assembly 1020 by apivot pin 11890 that extends between the right hand case member 1024 andthe left hand case member 1028.

When the clinician desires to close the anvil 1050 to clamp tissuewithin the end effector 1014, the clinician draws the closure trigger1040 toward the pistol grip portion 1034. As the clinician draws theclosure trigger 1040 toward the pistol grip portion 1034, the closurelinkage assembly 1180 moves the closure shuttle 1160 in the distal “A”direction until the closure linkage assembly 1180 moves into the lockedposition illustrated in FIG. 59. When in that position, the closurelinkage assembly 1180 will tend to retain the closure shuttle 1160 inthat locked position.

In various embodiments, to further retain the closure shuttle 1160 inthe closed position, the closure trigger 1040 may be provided with areleasable locking mechanism 1190 that is adapted to engage the pistolgrip portion 1034 and releasably retain the closure trigger 1040 in thelocked position. Other locking devices may also be used to releasablyretain the closure shuttle 1160 in the locked position.

In the embodiment depicted in FIG. 59, the closure trigger 1040 includesa flexible longitudinal arm 1192 that includes a lateral pin 1194extending therefrom. The arm 1192 and pin 1194 may be made from moldedplastic, for example. The pistol grip portion 1034 of the handleassembly 1020 includes an opening 1036 with a laterally extending wedge1037 disposed therein. When the closure trigger 1040 is retracted, thepin 1194 engages the wedge 1037, and the pin 1194 is forced downward(i.e., the arm 1192 is rotated clockwise) by the lower surface of thewedge 1037. When the pin 1194 fully passes the lower surface, theclockwise force on the arm 1192 is removed, and the pin 1194 is rotatedcounterclockwise such that the pin 1194 comes to rest in a notch 1038behind the wedge 1037 thereby locking the closure trigger 1040. The pin1194 is further held in place in the locked position by a flexible stop1039 extending from the wedge 1037.

To unlock the closure trigger 1040, the operator may further squeeze theclosure trigger 1040, causing the pin 1194 to engage a sloped back wall1041 of the opening 1036, forcing the pin 1194 upward past the flexiblestop 1039. The pin 1194 is then free to travel out of the opening 1036such that the closure trigger 1040 is no longer locked to the pistolgrip portion 1034. Further details of such arrangement may be found inU.S. patent application Ser. No. 11/344,020, filed Jan. 31, 2006 andentitled SURGICAL INSTRUMENT HAVING A REMOVABLE BATTERY, now U.S. Pat.No. 7,464,846, the relevant portions of which are herein incorporated byreference. Other releasable locking arrangements could also be employed.

As the closure shuttle 1160 is moved to the locked position, the closuretube assembly 1130 is moved distally on the spine assembly 1110 causingthe closure/opening tab 1054 on the anvil 1050 to be contacted by theproximal end of the horseshoe aperture 1142 in the distal closure tubeportion 1140 to thereby pivot the anvil 1050 to the closed (clamped)position. Thus, the clamping forces attained by the anvil 1050 duringthe clamping process are ultimately dependant upon the closure forcesgenerated by the closure tube assembly (represented by arrow 1196 inFIGS. 62 and 63) as it contacts the tab 1054 on the anvil 1050. As wasdiscussed above, prior closure tube arrangements lack means for limitingthe amount of actuation force applied to the closure/opening tab 1054 ofthe anvil 1050.

Various embodiments of the present invention address such shortcomingsof prior closure tube arrangements by including a force limiting membergenerally designated as 1200 for limiting the amount of closure force orload applied by the closure tube assembly to the closure/opening tab1054 of the anvil. For example, in one embodiment, the force limitingmember 1200 may comprise a cushioning member 1210 oriented adjacent tothe proximal end 1151 of the proximal closure tube portion 1150. Morespecifically and with reference to FIGS. 60 and 61, the cushioningmember 1210 comprises a wave spring assembly 1212 that may be supportedin a cavity 1169 formed in the closure shuttle 1160. The wave springassembly 1212 may be supported between an attachment post 1163 and theproximal end 1151 of the proximal closure tube portion 1150. In variousembodiments, the wave spring assembly 1212 may be fabricated from springsteel in the form depicted in the Figures. However, other cushioningarrangements or compliant member arrangements such as, for example,members fabricated from rubber, elastomer, polymer, foam rubber, etc.could be successfully employed to provided the closure tube assembly1130 with some freedom to axially move in the proximal direction toreduce the clamping force ultimately applied to the anvil 1050 duringthe anvil closing process which will be discussed in further detailbelow.

As can also be seen in FIGS. 60 and 61, the retention groove 1152 in theproximal closure tube portion 1150 comprises an area 1154 that has adiameter that is less than the outer diameter of the proximal closuretube portion 1150. The area 1154 is axially elongated to provide theclosure tube assembly 1130 to move axially and distally relative to theclosure shuttle 1160 a distance that is defined by the axial length(arrow 1155 in FIG. 60) of the retention groove 1152.

In this embodiment, as the closure trigger 1040 is moved toward thepistol grip portion 1032, the closure shuttle 1160 is advanced in thedistal direction (arrow A). As the closure shuttle 1160 moves distally,the closure tube assembly 1130 is also forced distally. As can be seenin FIGS. 62 and 63, distal end 1141 of the distal closure tube portion1140 is oriented to move axially up a ramp portion 1070 of the anvil1050. As the distal end 1141 contacts the anvil ramp 1070 and continuesto move distally up the ramp, it imparts a closure force to the anvil1050. The anvil trunnions 1052 are received in corresponding“kidney-shaped” slots 1064 in the proximal end of the elongate staplechannel 1060 and serve to guide the anvil 1050 in a desired closure pathwhich results in the clamping of the tissue between the staple formingundersurface of the anvil 1051 and the upper surface of the staplecartridge 42. As the anvil 1050 contacts the tissue, a resultingresistive force is transferred to the anvil 1050 and ultimately to thedistal end 1141 of the distal closure tube portion 1140. The magnitudeof such resistive force is effected by the thickness of the tissue beingclamped. Thinner tissues will exert less resistive forces than thickertissues. However, as the resistive forces are encountered, thecushioning member 1210 enables the closure tube assembly 1130 to moveproximally to ultimately limit the amount of closure force applied tothe anvil 1050 by the closure tube assembly 1130.

The magnitudes of the resistive forces for various thicknesses and typesof tissues may be determined and the wave spring 1212 sized accordinglysuch that the desired amount of clamping force is applied to the tissuebetween the anvil 1050 and the staple cartridge 42. The wave spring 1212may be sized and oriented such that when the anvil 1050 is at a fullycompressed position, the wave spring 1212 is not fully compressed or“bottomed out”.

FIGS. 64 and 65 illustrate other versions of closure tube assembliesthat may be employed to limit closure forces applied to the anvil 1050.As can be seen in those Figures, the force limiting members 1200 a, 1200b comprise spring sections 1212 a, 1212 b actually formed into thedistal closure tube portion 1140 a, 1140 b, respectively. While thespring sections 1140 a, 1140 b are depicted as being somewhat helical innature and formed in the distal closure tube portions 1140 a, 1140 b,those of ordinary skill in the art will understand that the springsections 1212 a, 1212 b may be provided in any portion of the closuretube assemblies 1130 a, 1130 b and could conceivable be provided indifferent configurations. Those of ordinary skill in the art willunderstand that in these embodiments, the retention groove 1152 in theproximal closure tube portion may not be elongated such that the closuretube assembly 1130 a, 1130 b is essentially not axially movable relativeto the closure shuttle 1160. In addition, while only one spring sectionis shown as being provided in the closure tube assembly, it isconceivable that more than one spring section may be formed in a singleclosure tube assembly. As with the above-described versions, as theresistive forces are encountered during clamping, the spring members1212 a, 1212 b enable their respective closure tube assembly 1130 a,1130 b to move proximally to ultimately limit the amount of closureforce applied to the anvil 1050.

FIGS. 66 and 67 illustrate another closure tube assembly of variousembodiments of the present invention that may be employed to limitclosure forces applied to the anvil 1050. As can be seen in thoseFigures, the force limiting member 1200 c comprises a leaf spring 1212 cformed in the distal end 1141 of the distal closure tube portion 1140 c.When the closure tube assembly 1130 c is actuated to move distally toclose the anvil 1050, the leaf spring 1212 c rides up the anvil ramp1070 and is free to move radially (arrows 1214 in FIG. 66) and axially(arrow 1216 in FIG. 66). As with the above-described versions, as theresistive forces are encountered during clamping, the leaf spring 1212 cenables the closure tube assembly 1130 c to move proximally (arrow B) toultimately limit the amount of closure force applied to the anvil 1050.

FIGS. 68 and 69 illustrate another embodiment of the present inventionthat may be employed to limit closure forces applied to the anvil 1050by the closure tube assembly 1130. As can be seen in those Figures, thisembodiment employs an anvil 1050 d that has a stepped ramp 1070 that isconfigured to be engaged by the distal end 1141 of the distal closuretube portion 1140. In particular, the anvil 1050 d depicted in thoseFigures has a series of steps 1074 d, 1076 d, 1078 d, 1080 d formedtherein. As the closure tube assembly 1130 is moved distally, the distalend 1141 starts to ride up the smooth portion 1072 d of the ramp 1070until it contacts the first step 1074 d. The closure tube assembly 1130will not advance further up the ramp 1070 d to apply a higher amount ofclosure force to the anvil until the actuation force applied to theclosure tube assembly 1130 attains a sufficient magnitude to cause thedistal end 1141 to bump up over the first step 1074 d and proceed toengage the next step 1076 d. The closure tube assembly 1130 will notadvance further up the ramp 1070 d until the actuation force attains asufficient magnitude to cause the distal end 1141 to bump up over thesecond step 1076 d at which time it will engage the next step 1078 d andso on. Thus, the stepped anvil 1050 d cooperates with the closure tubeassembly 1130 to provide a means for relating the amount of clampingforces ultimately applied to the tissue between the anvil 1050 d and thestaple cartridge 42 based on the amount of resistive forces generatedthereby and encountered by the closure tube assembly 1130 duringclamping. While four such steps have been disclosed, other numbers ofsteps may be employed. For example, only one such step may be used or 2,3, or more than 4 steps could conceivably be employed.

FIGS. 70-76 illustrate another unique and novel endocutter implementportion 1014 e of various embodiments of the present invention thatincludes an elongate channel 1060 e and an anvil arrangement 1050 e thatare “self adjusting” with respect to tissue thickness. In variousembodiments, the proximal end of the anvil 1050 e is pivotally attachedto the proximal end of the elongate channel 1060 e by mounting memberswhich may comprise trunnions 1052 e movably received in correspondingelongate slots 1064 e formed in the proximal end 1061 e of the elongatechannel 1060 e. As can be seen in FIGS. 70-74, at least one of the slots1064 e on each side of the elongate channel 1060 e (only one slot 1064 eis illustrated in FIGS. 70-74) and preferably both of the slots 1064 eeach have an end wall 1065 e that has a discrete number of predeterminedlocations in the form of detents or pivot nests 1066 e, 1067 e, 1068 e,1069 e formed therein. As can be seen in these Figures, the detents 1066e, 1067 e, 1068 e, 1069 e may each comprise a V-shaped notch that isadapted to seatingly receive the pointed end of a pawl 1080 e formed onthe corresponding trunnion 1052 e. It is conceivable that other detentand pawl configurations may be successfully employed. As can also beseen in FIGS. 70-74, this embodiment may further include a leaf spring1090 or other suitable biasing member for applying a downward biasingforce to the proximal end 1055 e of the anvil 1050 e. In variousembodiments, the leaf spring 1090 may be attached to the distal portion1116 of the spine assembly 1110 and oriented to bear upon the proximalend 1055 e of the anvil 1050 e.

As can be seen in FIG. 74, the slot 1064 e is sized relative to thetrunnion 1052 e to permit the trunnion 1052 e to find different clampedheights in response to the thickness of the tissue clamped between theanvil 1050 e and the cartridge 42 and the application of the closingmotion to the anvil 1050 e. The leaf spring 1090 serves to bias the pawl1080 e into a slightly upward position wherein it can be received in anyone of the notches 1066 e, 1067 e, 1068 e, 1069 e. As the anvil 1050 eis closed onto the tissue by means of distally advancing the closuretube assembly 1130 in the above-described manner, the tissue thicknessitself may dictate which of the notches 1066 e, 1067 e, 1068 e, 1069 ethat the pawl 1080 ultimately seatingly engages. Because the leaf spring1090 biases the pointed pawl upwardly, the pawl 1080 would find theuppermost notch 1069 e when no tissue is between the anvil 1050 e andthe cartridge 42 which would clamp the end effector 1014 e to is mostclosed position. See FIGS. 71 and 74. However, if during the clampingprocess, the anvil 1050 e and channel 1060 e encounter resistance, theleaf spring 1090 would be compressed and the anvil trunnions 1052 ewould find a lower pivot notch which would ultimately result in a largergap between the anvil 1050 e and the cartridge 42.

FIG. 70 illustrates the anvil 1050 e in an open position. FIG. 71illustrates the anvil 1050 e in its most closed position. The tissueclamping space or distance between the underside 1051 e of the anvil1050 e and the cartridge 42 is designated as “t”. FIG. 75 alsoillustrates the position of the anvil 1050 e relative to the staplecartridge 42 and tissue 1092 that has a thickness “t”. Similarly, FIG.73 illustrates the anvil 1050 e in its uppermost clamped positionwherein the distance between the underside 1051 e of the anvil 1050 eand the cartridge 42 is designated as “T”. FIG. 76 also illustrates theanvil 1050 e relative to the staple cartridge 42 and tissue 1094 thathas a thickness “T”. As can be seen in FIGS. 75 and 76, the staples 83in the thinner tissue 1092 are more tightly formed than the staples 83extending through the thicker tissue 1094.

FIGS. 77-88 illustrate another embodiment of the present invention thatmay be employed in connection with a circular stapler 1600 that includesa unique and novel apparatus for limiting the amount of compressionforce that can be generated between the anvil and the staple cartridgeto avoid over compressing and possibly destroying the tissue to bestapled. A variety of different circular staplers are known in the art.FIGS. 77-88 illustrate an exemplary circular stapler arrangement thatmay employ the benefits of various aspects of the subject invention. Itis conceivable, however, that the various embodiments of the presentinvention may be successfully employed with other stapler constructionswithout departing from the spirit and scope of the present invention.

As seen in FIG. 77, there is disclosed the circular stapler 1600includes a head 1610, an anvil 1700, an adjustment knob assembly 1800,and trigger 1664. The head 1610 is coupled to a handle assembly 1660 byan arcuate shaft assembly 1630. The trigger 1664 is pivotally supportedby the handle assembly 1660 and acts to operate the stapler 1600 when asafety mechanism 1670 is released. As will be discussed in furtherdetail below, when the trigger 1664 is activated, a firing mechanism(not shown in FIG. 77) operates within the shaft assembly 1630 so thatstaples 1618 are expelled from the head 1610 into forming contact withthe anvil 1700. Simultaneously, a knife 1620 operably supported withinthe head 1610 acts to cut tissue held within the circumference of thestapled tissue. The stapler 1600 is then pulled through the tissueleaving stapled tissue in its place.

FIG. 78 illustrates one form of anvil 1700 and head 1610 that may beemployed in connection with various embodiments of the subjectinvention. As can be seen in that Figure, the anvil 1700 may have acircular body portion 1702 that has an anvil shaft for attaching atrocar thereto. The anvil body 1702 has a staple forming undersurface1706 thereon and may also have a shroud 1708 attached to the distal endthereof. The anvil 1700 may be further provided with a pair of trocarretaining clips or leaf-type springs 1710 that serve to releasablyretain a trocar 1644 in retaining engagement with the anvil shaft 1704as will be discussed in further detail below. In the embodiment depictedin FIG. 78, a plastic knife board 1714 may be fitted into a cavity 1712in the anvil body 1702.

As can also be seen in FIG. 78, the head 1610 may comprise a casingmember 1612 that supports a cartridge supporting assembly in the form ofa circular staple driver assembly 1614 therein that is adapted tointerface with a circular staple cartridge 1616 and drive staples 1618supported therein into forming contact with the staple formingundersurface 1706 of anvil 1700. A circular knife member 1620 is alsocentrally disposed within the staple driver assembly 1614. The proximalend of the casing member 1612 may be coupled to an outer tubular shroud1631 of the arcuate shaft assembly 1630 by a distal ferrule member 1632.

FIGS. 79-82 illustrate one form of arcuate shaft assembly 1630 that maybe employed with various embodiments of the present invention. As can beseen in FIGS. 79 and 80, the arcuate shaft assembly 1630 may include acompression shaft 1634, a distal compression shaft portion 1635, a toptension band 1636, a bottom tension band 1638 and a spacer band 1640that are assembled within the outer tubular shroud 1631 (FIG. 80). Atrocar tip 1644 may be attached to the top tension band 1636 and bottomtension band 1638 by fasteners 1646. The proximal ends of the toptension band 1636 and bottom tension band 1638 may be attached to adistal end of an adjustment shaft 1650. As can be seen in FIG. 80, thetrocar tip 1644 may be inserted into the anvil shaft 1704 of the anvil1700 and retained in engagement by trocar retaining clips 1710.

As can be seen in FIG. 80, the distal compression shaft portion 1635 iscoupled to the staple driver assembly 1614. Thus, axial movement of thecompression shaft 1634 within the outer tubular shroud 1631 causes thestaple driver assembly 1614 to move axially within the casing member1612. As will be discussed below, actuation of the firing trigger 1664will cause the compression shaft 1634 to move in the distal direction(arrow “DD”) thereby driving the staple driver assembly 1614 distally tofire the staples 1618 into forming contact with the staple formingundersurface 1706 of the anvil 1700. As the staple driver assembly 1614is driven distally, it also drives the distal end 1622 of the knife 1620through the tissue held within the circumference of the stapled tissueinto the knife board 1714 mounted in the anvil 1700. The knife board1714 may be fabricated from plastic or other suitable material that willpermit the sharp distal end 1622 of the knife 1620 to penetrate andachieve a desirable cutting action through the clamped tissue.

In various embodiments, the adjusting shaft 1650 is axially movablysupported within a handle assembly 1660 that may comprise two handlecasing segments 1661, 1662 that are interconnected together by suitablefastener arrangements for ease of assembly. The trigger 1664 ispivotally attached to the handle assembly 1660 by a pivot pin 1666. Aspring 1668 is supported on pivot pin 1666 and serves to bias thetrigger 1664 away from the handle assembly 1660 to an unactuatedposition. A safety yoke 1670 is pivotally coupled to the triggerassembly 1664 by pin 1672 such that it can be pivoted between a safeposition wherein the trigger 1664 cannot be depressed towards the handle1660 and an off position wherein the safety yoke 1670 does not inhibitpivotal travel of the trigger assembly 1664 toward the handle assembly1660. As can be seen in FIG. 79, the trigger 1664 may have a pair offins 1665 that are sized to be received in slots 1676 in a firing clip1674 that is attached to the proximal end 1637 of compression shaft 1634by a protrusion 1639 or other suitable fastener arrangements. Sucharrangement permits the distal axial movement (arrow “DD”) and theproximal axial movement (arrow “PD”) of the compression shaft 1634 bypivoting the trigger 1664 as will be further discussed below. Thetrigger 1664, the compression shaft portions 1634, 1635 and the firingcap 1674 and other related components may comprise a firing assemblygenerally designated as 1675.

As can be seen in FIGS. 79 and 81, the adjustment shaft 1650 has adistal portion 1651 that is attached to the top and bottom tension bands1636, 1638 and a proximal portion 1652 that is adjoined to the distalportion 1651 by a reduced diameter segment 1653. The proximal portion1652 is axially received within an axial passage 1722 in the distalclosure nut 1720 that is keyed onto or otherwise attached to a proximalclosure nut 1740 to form a closure nut assembly generally designated as1721 such that the distal closure nut 1720 and the proximal closure nut1740 may rotate together. The distal closure nut 1720 may further have adistally extending hub portion 1724 that abuts an inwardly extendingretainer flange 1667 formed inside the handle assembly 1660. See FIG.81. Such arrangement permits the distal closure nut 1720 to freelyrotate within the handle assembly 1660, but is unable to move axiallytherewithin. Likewise, the proximal end portion 1652 of the adjustmentshaft 1650 is axially received within an axial passage 1742 within theproximal closure nut 1740. A circumferentially extending groove 1744 maybe provided in the outer surface of the proximal closure nut 1740 forreceiving an inwardly protruding proximal retainer flange 1669 formed onthe proximal end of the handle assembly 1660. Such arrangement serves topermit the proximal closure nut 1740 to freely rotate relative to thehandle assembly 1660.

Also in various embodiments, the closure knob assembly 1800 is attachedto the proximal end 1741 of the proximal closure nut 1740. In oneembodiment for example, the proximal end 1741 of the proximal closurenut 1740 may be formed with a proximally extending tapered hub portion1746 that is adapted to be nonrotatably received in an axial passage1832 in a clutch hub portion 1830. See FIG. 81. The tapered hub portion1746 can also be formed with a key or spline arrangement tonon-rotatably affix the hub portion 1746 with the clutch hub portion1830. Other fastener arrangements and methods may be employed tonon-movably attach the hub portion 1746 of the proximal closure nut 1740to the clutch hub portion 1830. Thus, rotation of the clutch hub portion1830 will cause the proximal closure nut 1740 and distal closure nut1720 to also rotate.

As can also be seen in FIGS. 81, 83, and 84, the knob assembly 1800 mayfurther include a proximal cap portion 1810 and a distal cap portion1820. The proximal end 1831 of the clutch hub portion may be received ina circular slot 1814 formed in a distal end of the proximal cap portion1810. The slot 1814 may be sized to permit the proximal cap portion 1810to rotate about the proximal end 1831 of the clutch hub portion 1830. Inaddition, the proximal cap portion 1810 may have a protrusion 1812 thatrotatably extends into the axial passage 1832 in the clutch hub portion1830. Also in various embodiments, the closure knob assembly 1800 maycomprise a distal cap portion 1820 that is rigidly and non-rotatablycoupled to the proximal cap portion 1810. Those of ordinary skill in theart will understand that the closure knob assembly 1800 may befabricated in multiple parts for ease of assembly of various componentsof the instrument. In various embodiments, the mating ends of theproximal cap portion 1810 and distal cap portion 1820 may be configuredwith complementary flanged portions 1813, 1823, respectively as shown inFIGS. 81 and 83, that are interconnected by adhesive, welding, etc. orother fastener arrangements may be employed. Thus, when fastenedtogether, the proximal cap portion 1810 and the distal cap portion 1820rotate together as a unit.

As can further be seen in FIGS. 81 and 83, various embodiments maycomprise a slip clutch assembly generally designated as 1821. The slipclutch assembly 1821 may take various forms that are supported by or areintegrally formed in the adjustment knob assembly 1800. In oneembodiment, for example, the distal cap portion 1820 may be providedwith an inwardly extending cap flange 1824 that is in confrontingorientation with an outwardly extending clutch flange 1834 formed on theclutch hub portion 1830. A first friction pad 1840 is non-rotatablyaffixed to the inwardly extending cap flange 1824. A pad cavity 1836 maybe formed within the clutch flange 1834 for movably receiving a secondfriction pad 1850 and a wave spring 1852 therein. The second frictionpad 1850 may be provided with splines or keys (not shown) to preventrotation thereof in the cavity 1836, but facilitate some axial travelthereof within the cavity 1836. In various embodiments, the first andsecond friction pads 1840, 1850 may be fabricated from, for example,liquid crystal polymer, Nylon, ULTEM®, polycarbonate, aluminum, etc.

In various embodiments, the proximal portion 1652 of the adjustmentshaft 1650 has a low pitch thread segment 1654 formed therein thatcommunicates with a higher pitched threaded segment 1657. See FIG. 79.As can be seen in FIG. 81, a drive pin 1726 protrudes inwardly into theaxial passage 1722 for “driving” engagement with the threaded segments1654, 1657 in the adjustment shaft 1650. In addition, the proximal end1652 of the adjustment shaft 1650 has a threaded section 1658 adaptedfor threaded engagement with a threaded cavity 1748 in the tapered hubportion 1746 of the proximal closure nut 1740. In various embodiments,the drive pin 1726 is oriented in the distal closure nut 1720 such thatwhen the drive pin 1726 is still engaged with the low pitched distalthread segment 1654 of the adjustment shaft 1650, the threaded end 1658of the adjustment shaft 1650 has sufficiently threadedly engaged thethreaded cavity 1748 in the tapered hub portion 1746 of the proximalclosure nut 1740 for threaded travel therein as the closure knobassembly 1800 is rotated. In particular, as the closure knob assembly1800 is rotated in the counterclockwise (“CC”) direction, the adjustmentshaft 1650 is moved in the distal direction “DD” by virtue of theengagement of the drive pin 1726 with the threaded segments 1654 and1657 formed in the attachment rod 1650. Those of ordinary skill in theart will appreciate that rotation of the distal closure nut 1720 whenthe drive pin 1726 is engaged with the distal threaded segment 1654 willresult in fastener axial movement of the adjustment shaft 1650 than whenthe drive rod 1726 is engaged with the threaded segment 1567 which has alarger pitch than the threaded segment 1564. Axial movement of theadjustment shaft 1650 moves the top and bottom tension bands 1636, 1638,the trocar tip 1644 and the anvil 1700 (when attached to the trocar tip1644) in the distal “DD” direction away from the head 1610.

To close the anvil 1700 or move it toward the head 1610 and staplecartridge 1616 supported therein in the “PD direction, the surgeonbegins to turn the closure knob assembly 1800 in the clockwise (“CW”)direction. The frictional forces generated between the first and secondfriction pads 1840, 1850 serves to retain the closure knob assembly 1800in frictional engagement with the clutch hub 1830 which is non-rotatablyattached to the proximal closure nut 1740. Because the proximal closurenut 1740 is non-rotatably affixed to the distal closure nut 1720, thedistal closure nut 1720 is also rotated in the clockwise direction.Rotation of the distal closure nut 1720 results in the drivingengagement of the drive pin 1726 with either of the thread segments1654, 1657 (depending upon the position of the adjustment shaft 1650relative thereto) and causes the adjustment shaft 1650 to be drawn inthe proximal direction (“PD”). As the adjustment shaft 1650 is drawn inthe proximal direction, the threaded end 1658 of the adjustment shaft1650 threadably engages the threaded cavity 1748 of the tapered threadedhub portion 1746 of the proximal closure nut 1740 and reduced diametersegment 1653 moves adjacent to the drive pin such that the drive pin isno longer in driving engagement with the adjustment shaft 1650. Now, thethreaded end 1652 is in full threaded engagement with the threaded hole1748 in the proximal closure nut 1740. Further rotation of the closureknob assembly 1800 in the clockwise direction continues to draw theadjustment shaft 1650 in the proximal direction “PD”. As the adjustmentshaft 1650 is drawn in the proximal direction, the anvil 1700 is movedtowards the cartridge 1616 supported in the staple driver assembly 1614to clamp an amount of tissue therebetween. As the anvil 1700 continuesto move toward the staple cartridge 1616, the tissue is compressedtherebetween and resists further travel of the anvil 1700 in theproximal direction.

In various embodiments, to prevent the tissue from being over compressedwhich could result in damaging or killing the tissue to be stapled, thecomposition of the first and second friction pads 1840, 1850 and thesize of the spring 1852 are selected such that when a predeterminedamount of tissue compression is attained, the friction pads 1840, 1850begin to slip to prevent further rotation of the closure knob assembly1800 from being transferred to the clutch hub 1830. Thus, even if thesurgeon continues to rotate the closure knob assembly 1800 after thetissue has been adequately compressed, such further rotation will notresult in continued movement of the adjustment shaft 1650 (and anvil1700) in the proximal direction to avoid over compressing the tissue.For example, in various embodiments, the instrument may be constructedsuch that the maximum amount of compression forces that may be appliedto the tissue between the anvil 1700 and the cartridge 1616 may beapproximately 150 pounds per square inch. For such applications, thefirst and second friction pads 1840, 1850 and the wave spring 1852 maybe so configured to permit slippage between the first and secondfriction pads 1840, 1850 if the closure knob assembly 1800 continues tobe rotated after that maximum amount of compression force has beenattained. In such example, the rotation of the closure knob assembly1800 may generate an approximate amount of torque of, for example, 15inch pounds which overcomes the frictional forces that are establishedwhen the maximum amount of desirable compression has been attained(which serves to retain the first and second friction pads 1840, 1850 infrictional engagement with each other) and permit the desired slippagebetween the first and second friction pads. In various embodiments, toensure that the adjustment shaft 1650 is moved distally when the closureknob assembly 1800 is rotated in a counterclockwise direction, a seriesof circumferentially extending ratchet teeth 1816 may be formed in theinterior of the closure knob assembly 1800 for engagement withcircumferentially extending engagement teeth 1835 formed on thecircumference of the clutch flange 1834. See FIGS. 83 and 84. The teeth1816, 1835 may be configured such that when the closure knob assembly1800 is rotated in the clockwise direction to move the anvil 1700 towardthe cartridge 1616, the teeth 1816 on the closure knob assembly 1800slip over the teeth 1835 formed on the clutch flange 1834. However, whenthe closure knob assembly 1800 is rotated in the counterclockwisedirection, the teeth 1816 engage teeth 1845 on the clutch flange 1834 tocause the clutch hub 1830 and the proximal and distal closure nuts 1720,1740 to rotate therewith to move the anvil 1700 away from the cartridge1616.

As indicated above, various embodiments may be provided with a safetyyoke 1670 that prevents actuation of the trigger assembly 1664 when thesafety yoke 1670 is in a “safe” or engaged position. In variousembodiments, a safety spring 1686 may be journaled on the adjustmentshaft 1650 and be received on the hub portion 1724 of the distal closurenut 1720. The spring 1686 may be oriented between the distal closure nut1720 and an upstanding end wall portion 1688 of the safety release 1684.See FIG. 81. The safety spring 1686 serves to bias the safety release1684 in the distal direction and into contact with the safety yoke 1670to prevent the safety yoke from being pivoted to an off position whereinthe trigger 1664 may be actuated. Also in these variations, a rod clip1690 may be attached to the adjustment shaft 1650 by and adjusting screw1692 that extends through a slot (not shown) in the rod clip 1690. Therod clip 1690 may be so located on the adjustment shaft 1650 such thatwhen the adjustment shaft 1650 has been axially positioned in its mostproximal position which results in the maximum amount of desirablecompression being applied to the tissue or in a position wherein theanvil 1700 has begun to clamp the tissue, but has not yet attained thepredetermined maximum amount of compression force, the rod clip 1690 hascontacted the upstanding end wall 1688 and moved it proximally asufficient distance to move the distal end 1685 of the safety release1684 out of retaining engagement with the safety yoke 1670. The surgeonmay then pivot the safety yoke 1670 to the off position thereby enablingthe trigger 1664 to be depressed.

Various embodiments of the invention may also be fitted with a stapleform indicator 1676 that may be pivotally mounted within the handleassembly 1660 by a pivot pin 1678. The staple form indicator 1676 mayhave a pointer end portion 1679 that is viewable through a viewingwindow 1663 (FIG. 77) formed in the handle assembly 1660. The endportion 1679 may be biased in the distal direction by an indicatorspring 1680. As can be seen in FIG. 79, the staple form indicator 1676may be formed with a tab 1682 that is oriented for engagement by ahooked end 1685 of a safety release 1684. As the safety release 1684 ismoved proximally in connection with the proximal movement of theadjustment shaft 1650, the hooked end 1685 causes the staple formindicator 1676 to pivot in the proximal direction. An indicator plate(not shown) may be positioned within the window 1663 and so calibratedsuch the indicator 1676 cooperates with the indicator plate to indicatethe amount of distance between the anvil 1700 and the cartridge 1616.

One exemplary method of using the circular stapler 1600 will now bedescribed with reference to FIGS. 85-88. When performing an anastomosisusing a circular stapler, the intestine 1900 may be stapled using aconventional surgical stapler with multiple rows of staples beingemplaced on either side of a target section (i.e., specimen) ofintestine 1900. FIG. 85 illustrates the liner staple lines 1910, 1920.The target section is typically simultaneously cut as the section isstapled. The target section has already been removed in FIG. 85. Next,after removing the target specimen, the surgeon inserts the anvil 1700into the proximal portion 1902 of the intestine 1900, proximal of thestaple line 1910. This is done by inserting the anvil head 1700 into anentry port cut into the proximal intestine portion 1902 or the anvil1700 can be placed transanally, by placing the anvil 1700 on the distalend of the stapler 1600 and inserting the instrument through the rectum.Next, the surgeon attaches the anvil 1700 to the trocar tip 1644 of thestapler 1600 and inserts the anvil 1700 into the distal portion 1906 ofthe intestine 1900. The surgeon may then tie the distal end 1904 of theproximal section 1902 of the intestine 1900 to the anvil shaft 1704using a suture 1912 or other conventional tying device and also tie theproximal end 1908 of the distal intestine portion 1906 around the anvilshaft using another suture 1914. See FIG. 86. The surgeon then begins torotate the closure knob assembly 1800 in the clockwise direction to drawthe anvil 1700 toward the cartridge 1616 supported in the staple driver1614 to close the gap between the anvil 1700 and cartridge 1616 andthereby engage the proximal end 1908 of the distal intestine portion1906 with the distal end 1904 of the proximal intestine portion 1902 inthe gap “G” therebetween. See FIG. 87. The surgeon continues to rotatethe closure knob assembly 1800 until the first and second friction pads1840, 1850 slip and the desired amount of compression (the desired gapG) is attained. When in that position, the surgeon may then pivot thesafety yoke 1670 to the off position and fire the stapler 1600 bydepressing the firing trigger 1664. Depressing the trigger 16614 causesthe compression shaft 1634 to drive the staple driver 1614 distally todrive the staples 1618 to be driven through both ends 1904, 1908 of theintestine 1900, thereby joining the portions 1902 and 1906 and forming atubular pathway. Simultaneously, as the staples 1618 are driven andformed, the knife 1620 is driven through the intestinal tissue ends 1904and 1908, cutting the ends adjacent to the inner row of staples 1618.The surgeon then withdraws the stapler 1600 from the intestine and theanastomosis is complete.

FIGS. 89-95 illustrate another stapler embodiment 1600 a of the presentinvention. Stapler 1600 a may essentially employ the same componentsdescribed above with respect to stapler 1600 except for the changes thatwill be discussed in detail below. For example, in this embodiment, aslip clutch assembly may not be employed. However, this embodiment mayemploy a closure actuator assembly 2000 that includes a proximal capportion 2010 and a distal cap portion 2040 that are rotatably retainedtogether.

More specifically, as shown in FIGS. 90 and 91, in various embodiments,the proximal cap portion 2010 may have a sleeve portion 2012 that issized to extend over the outer wall portion 2044 of the distal capportion 2040 and be retained thereon by virtue of an inwardly extendingflange 2014 formed on the sleeve portion 2012. Flange 2014 may besnapped over an outwardly protruding rim 2046 formed on thecircumference of the wall portion 2044 of the distal cap portion 2020.Such arrangement serves to attach the proximal cap portion 2010 to thedistal cap portion 2040 while facilitating its rotation relativethereto. To facilitate ease of attachment, a beveled edge 2048 may beprovide on the end 2041 of the wall portion 2044.

As can also be seen in FIGS. 90 and 91, the distal cap portion 2040 mayfurther have a cap hub portion 2050 that has a proximal end 2052 thatmay be rotatably received in a circular slot 2016 formed in the proximalcap portion 2010. The slot 2016 may be sized relative to the cap hubportion 2050 such that the proximal cap portion 2010 can freely rotatearound the cap hub portion 2050. In addition, the proximal cap portion2010 may have a protrusion 2018 that rotatably extends into an axialpassage 2054 in the cap hub portion 2050 to provide additionalrotational support to the closure knob assembly 2000. As can be seen inFIG. 90, the proximal end 1741 of the proximal closure nut 1740 may beformed with a proximally extending tapered hub portion 1746 that isadapted to be nonrotatably received in the axial passage 2054 in the caphub portion 2050. The tapered hub portion 1746 may also be formed with akey or spline arrangement to non-rotatably affix the hub portion 1746with the cap hub portion 2050. Other fastener arrangements and methodsmay be employed to non-movably attach the hub portion 1746 of theproximal closure nut 1740 to the cap hub portion 2050. Thus, rotation ofthe cap hub portion 2050 will cause the proximal closure nut 1740 anddistal closure nut 1720 to also rotate in the manners described aboveand axially advance the adjustment shaft 1650 distally or proximallydepending upon the direction in which the proximal and distal closurenuts are rotated.

Rotation of the proximal and distal closure nuts 1740, 1720 is attainedby rotating the proximal cap portion 2010 relative to the distal capportion 2040. The interaction between the proximal cap portion 2010 andthe distal cap portion 2040 may be controlled by a variable forcegenerating member 2060 that interconnects those components and serves toapply a resistive force to the proximal cap portion 2010 in relation tothe amount of compression experienced by the tissue compressed betweenthe anvil 1700 and the staple cartridge 1616. In various embodiments,for example, the variable force generating member may comprise a spiralspring 2060. In some embodiments, the innermost end 2062 of the spiralspring 2060 may be configured as shown in FIG. 92 and inserted into aretaining slot 2020 in the proximal cap portion 2010. End 2062 of spring2060 may also be attached to the proximal cap portion 2010 by otherfastener arrangements. Likewise, the outer end 2064 of the spring 2060may be configured as shown in FIG. 92 and received in a retention slot2045 formed in the distal cap portion 2040. However, the outer end 2064of spring 2060 may be attached to the distal cap portion 2040 by othersuitable fastener arrangements.

In various embodiments, a reference indicator mark 2070 may be providedon the proximal cap portion 2010 such that it aligns with acorresponding initial mark 2072 on the outer wall 2044 of the distal capportion 2040 when the stapler 1600 a is in the unadvanced or neutralposition. See FIGS. 89 and 95. When in that aligned position, the spiralspring 2060 may essentially be unloaded or it may be under a relativelysmall amount of load necessary to retain the proximal cap portion 2010in that starting position. Rotation of the proximal cap portion 2010 inthe clockwise “CW” direction will be transferred to the distal capportion 2040 through the spring 2060 and to the proximal closure nut1740 attached to the distal cap portion 2040. Rotation of the proximalclosure nut 1740 also causes the distal closure nut 1720 to rotate andaxially draw the adjustment shaft in the proximal “PD” direction. Whenthe adjustment shaft 1650 is drawn proximally, is also causes the anvil1700 to move towards the cartridge because it is attached to the trocartip 1644 which is attached to the adjustment shaft 1650 by means of thetop and bottom tension bands 1636, 1638 as was discussed above. As theanvil 1700 moves closer to the staple cartridge 1616 supported in thehead 1610, the tissue 1904, 1908 clamped therebetween begins to compressand resist further travel of the anvil 1700 to the cartridge. See FIG.93. Such resistive compressive force also must be overcome by the springload to enable the anvil 1700 to further compress the tissue 1904, 1908between the anvil 1700 and the cartridge 1616.

In various embodiments, the amount of spring load (“L1”) necessary toattain a minimum amount of tissue compression (“Min”) may be determinedas well as the amount of spring load “(L2”) required to attain a maximumamount of tissue compression (“Max”) may also be determined. Inaddition, the distance “D1” that the proximal cap portion 2010 must berotated from the neutral position to generate spring load L1 and thedistance “D2” that the proximal cap portion 2010 must be rotated togenerate spring load “L2” may be determined. The graph depicted in FIG.94 illustrates an example of a relationship between these parameters.Those of ordinary skill in the art will appreciate that suchrelationships may change depending upon the spring used and variousother factors such as, for example, frictional forces encountered by themoving components of the device.

As can be seen in FIG. 95, a second indicator mark or indicia 2080corresponding to the position of the proximal cap portion 2010 when ithas been rotated to generate the minimum amount of compression force“Min” is provided on the outer wall 2044 of the distal cap portion 2040such that the second indicia 2080 coincides with the reference indicator2070 on the proximal cap portion 2010. Likewise a third indicator markor indicia 2082 may be provided on the outer wall 2044 of the distal capportion 2040 such that the third indicia 2082 coincides with thereference indicator 2070 on the proximal cap portion 2010 when theproximal cap portion 2010 has been rotated to that position whichgenerates the maximum amount of compression force “Max”. See FIG. 95.Those of ordinary skill in the art will recognize that a variety ofdifferent indicia arrangements may be employed without departing fromthe spirit and scope of the present invention. For example, the area2084 on the outer wall 2044 of the distal cap portion 2040 between thesecond indicia member 2080 and the third indicia member 2082 may bepainted or other wise colored green to indicate to the surgeon that ifthe reference indicator 2070 is located in that region and acceptableamount of compression force may be attained.

Thus, in these embodiments, the spring 2060 provides a means forinterrelating the amount of compression experienced by the tissuelocated between the anvil 1700 and the staple cartridge 1616 and thedistance that the proximal cap portion 2010 must be rotated to attainthat amount of compression. Such arrangement permits the use ofreference indicators and indicia on the proximal and distal cap portions2010, 2040 to enable the surgeon to accurately determine when the anvilhas been located in a position that will result in acceptable stapleformation. These reference indicators and indicia can be so oriented toinform the surgeon when the anvil has been moved to a position that willresult in a minimum amount of compression being applied to the tissuewhile still facilitating the formation of sealing staples. Likewise,such reference indicators and indicia may be so oriented to inform thesurgeon that the anvil has been moved to a position that will result ina maximum amount of compression being applied to the tissue while stillfacilitating the formation of sealing staples.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. For example, while variousmanually operated surgical instruments have been depicted for clarity,it should be appreciated that such devices may also be roboticallymanipulated. In addition, those skilled in the art will appreciate thatthe embodiments, features and improvements disclosed herein may bereadily employed in connection with a variety of other known surgicalcutter/staplers, staplers, etc. that may have application in open,laparoscopic, endoscopic and/or intralumenal surgical procedures. Inparticular, such unique and novel features may be practiced inconnection with linear staplers, cutters, contour cutters, etc. Thus,the scope and protection afforded to the various embodiments disclosedherein should not be limited solely to endocutter-type surgicalstaplers.

While several embodiments of the invention have been described, itshould be apparent, however, that various modifications, alterations andadaptations to those embodiments may occur to persons skilled in the artwith the attainment of some or all of the advantages of the invention.For example, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include a combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of particular pieces or parts of thedevice can be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Those ofordinary skill in the art will appreciate that the reconditioning of adevice can utilize a variety of different techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Preferably, the invention described herein will be processed beforesurgery. First a new or used instrument is obtained and, if necessary,cleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

As used herein, the term “fluidically coupled” means that the elementsare coupled together with an appropriate line or other means to permitthe passage of pressurized gas therebetween. As used herein, the term“line” as used in “supply line” or “return line” refers to anappropriate passage formed from rigid or flexible conduit, pipe, tubing,etc. for transporting fluid from one component to another.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

As known in the art, surgical staples can be used to hold several layersof tissue together after the tissue has been resected, for example.Often, as described above, a surgical stapler is used to deform thestaples from an undeployed shape into a deployed, i.e., deformed, shape.Referring to FIG. 27, the staples, such as staples 83, for example,include a base, or crown, and deformable legs extending therefrom. Inuse, the deformable legs are typically deformed toward the crown by ananvil in the surgical stapler. Referring to FIG. 27, the amount of thisdeformation is usually dependent upon the thickness of the tissue beingstapled. More particularly, if the tissue is thinner, the anvil isbrought closer to the staple cartridge before the anvil contacts thetissue and, as a result, the staples will have less distance to bedeployed before they are deformed against the anvil. For example, thelegs of the staple on the left in FIG. 27 are inserted through thinnertissue while the legs of the staple on the right are inserted throughthicker tissue and, as a result, the legs of the staple on the left aredeformed more than the legs of the staple on the right. As a result ofthe foregoing, a common staple design can be readily adapted to varioustissues having different thicknesses.

As described above, referring to FIG. 27, the legs of staples 83 arebent toward the base, or crown, of the staple. More particularly, theends of the legs are curled by the anvil of the stapler until thedesired deformation is achieved. Stated another way, when the ends ofthe legs contact the anvil of the stapler, the ends are guided by theanvil such that the legs are continuously bent into an arcuateconfiguration until the staple is deformed into a “B” shape, forexample. In embodiments where the staple has long legs, and/orembodiments where the staples are used in very thin tissue, the legs maybe curled significantly such that their ends project outwardly from thestaple. In these embodiments, the ends may be sharp and may impinge onsurrounding tissue causing discomfort to the patient. To ameliorate thisproblem, the present invention includes staple 1300 which can be bent insegments, as opposed to a continuous arcuate shape as described above.

Similar to the above, referring to FIG. 96, staple 1300 includes crown1302 and deformable legs 1304 and 1306 extending therefrom. Legs 1304and 1306 include first notches 1310, second notches 1312, and thirdnotches 1313 therein. In use, referring to FIG. 105, when ends 1308 oflegs 1304 and 1306 contact pockets 1314 of anvil 1316, ends 1308 can beguided toward each other, for example. As the staple is further driventoward anvil 1316 by sled driver 78, referring to staple 1300 b, legs1304 and 1306 may bend significantly at first notches 1310. Referring toFIG. 97, owing to the reduced cross-section of legs 1304 and 1306 atfirst notches 1310, legs 1304 and 1306 are more susceptible todeformation at this location. For example, when legs 1304 and 1306 arebent at notches 1310, first segments 1318 may bend at an approximately90 degree angle, for example, with respect to second segments 1320 oflegs 1304 and 1306. In other embodiments, first segments 1318 may bebent at any suitable angle with respect to second segments 1320.

Further to the above, referring to FIG. 98, second notches 1312 in legs1304 and 1306 permit second segments 1320 to bend with respect to thirdsegments 1322 at an approximately 90 degree angle, for example. In otherembodiments, second segments 1320 may be bent at any other suitableangle with respect to third segments 1322. Similar to the above, notches1313 permit third segments 1322 to bend with respect to fourth segments1325. As a result of notches 1310, 1312, and 1313, legs 1304 and 1306may not be bent into a continuous curl as described above; rather, theycan be bent into a segmented, rectangular configuration. As a result ofthe above, staples having long legs 1304 and 1306 may be deformed in amanner such that the ends of the deformable members do not extendoutwardly from the staple, rather, they can be positioned intermediatelegs 1304 and 1306 as illustrated in FIG. 99. While the legs of theillustrated staples in FIGS. 96-105 have three notches and foursegments, various embodiments are envisioned which have additional, orless, notches and segments. Furthermore, while the segments of thestaple legs described above are substantially straight, variousembodiments are envisioned in which the segments are curved,curvilinear, or other otherwise suitably configured to achieve a desiredshape.

To facilitate the bending of third segments 1322 with respect to fourthsegments 1325, for example, crown 1302 may include a forming surface, oranvil, for guiding and/or deforming legs 1304 and 1306 when they contactcrown 1302. More particularly, referring to FIGS. 99 and 101-104, aslegs 1304 and 1306 are being deformed from the shape illustrated in FIG.98 to the shape illustrated in FIG. 99, ends 1308 of deformable members1304 and 1306 may contact crown 1302. To guide ends 1308, anvil 1323 ofcrown 1302 includes recesses 1324 which can direct ends 1308 to moveoutwardly as illustrated in FIG. 99 or in any other suitable direction.In various embodiments, recesses 1324 may not deform legs 1304 and 1306significantly, however, in the illustrated embodiment, recesses 1324 areconfigured to deform legs 1304 and 1306 at an approximately 90 degreeangle. In various embodiments, anvil 1316 of the stapler and anvil 1323in crown 1302 can co-operate to deform staple 1300 into the shapeillustrated in FIG. 99, for example, or any other suitable shape.

In various embodiments, although not illustrated, a forming surface, oranvil, can be included in staple cartridge 1326 in addition to, or inlieu of, anvil 1323 in crown 1302. In these embodiments, anvil 1316deforms legs 1304 and 1306 such that ends 1308 contact the recesses instapler cartridge 1326. Similar to the above, the staple cartridgerecesses can be configured to guide and/or deform legs 1304 and 1306when they contact stapler cartridge 1326. In various embodiments, anvilson both crown 1302 and stapler cartridge 1326 can be utilized to deformand/or guide the staple. In the illustrated embodiment, crown 1302includes material 1303 overmolded onto base 1301. As discussed ingreater detail below, material 1303 can be comprised of a plasticmaterial, for example, a bioabsorbable material, and/or anon-bioabsorbable material. In at least one of these embodiments, thematerial 1303 is formed around a single continuous wire comprising base1301 and deformable members 1304 and 1306. In other embodiments,deformable members 1304 and 1306 can include separate deformable membersembedded in plastic material 1303. Further, in various embodiments, thewire comprising base 1301 can be deformed to provide the recesses andanvils described above.

Referring to FIGS. 106 and 107, similar to the above, the staple, invarious embodiments, can include several necked down sections in thestaple legs which can be configured to cause the staple legs to deformand/or buckle at the necked down sections. More specifically, staple1340 can include several necked-down or tapered sections 1342 whichallow staple legs 1344 to deform in segments as described above. Taperedsections 1342, similar to notches 1310, 1312, and 1313, provide a stressconcentration area. Stress concentration areas are typically locationsin which a loaded member, for example, will fail. Stated another way,stress concentration areas may magnify the stress in a particular areaof a loaded member causing the loaded member to yield, or plasticallystrain, at the stress concentration area before the remainder of theloaded member plastically strains. As used herein, the term “yield”generally refers to the point of maximum stress and/or strain abovewhich a material will no longer behave in a completely elastic manner.However, various embodiments are envisioned in which the materials usedherein do not have a traditional yield point, for example. Thesematerials can include materials which strain plastically as soon as theyare stressed and/or super-elastic materials which do not have adiscernable yield point. These materials can include shape memoryalloys, such as Nitinol, for example, that allow for large straindeformations during the above-described forming processes. Typically,engineers are charged with eliminating stress concentration areas toachieve a desired goal; however, according to the teachings of thepresent invention, stress concentration areas can be utilized to achievethe above-described goals.

In various embodiments, referring to FIGS. 108-110, staple 1329 includesbase portion 1331 and two deformable legs 1333 extending therefrom. Legs1333 can each include a first portion 1335 having a substantially roundcross-section and a second portion 1337 having a substantially flatcross-section. In at least one embodiment, legs 1333 and base 1331 arecomprised of a metal wire that is coined, or formed, on its ends tocreate substantially flat portions 1337. As known in the art, coining,or forming, a metal wire may be performed with a stamping press beforeand/or after, the wire is bent into the “U” shape illustrated in FIG.108. Referring to FIG. 110, legs 1333 are configured such that flatportions 1337 can be bent to secure tissue within the staple while roundportions 1335 can remain substantially unbent. In use, as a result,staple 1329 can be used to secure thicker tissues. More specifically,owing to substantially unbent portions 1335, thicker tissues can beaccommodated between portions 1335 while flat portions 1337 can be bentto retain the tissue therebetween. The amount in which flat portions1337 are deformed is typically dependent upon the thickness of thetissue captured in the staple.

In various embodiments, referring to FIG. 111, staple 1441 can includedeformable legs 1443 which have a tapered configuration. Moreparticularly, staple legs 1443 can include a base portion 1444 that hasa larger cross-section than the cross-section of tip portion 1445. Inuse, similar to the above, staple 1441 can accommodate thicker tissuesas, owing to the thicker cross-section of base portions 1444, baseportions 1444 may remain substantially unbent while tip portions 1445are bent to retain the tissue in the staple. In other variousembodiments, referring to FIG. 112, staple 1446 can include severalstepped portions 1447 and 1448 which allow some portions of legs 1449 tobe bent, some portions to be only partially bent, and other portions toremain substantially unbent. The suitable amount and configurations ofthe stepped portions may be selected to accommodate the type and/orthickness of the tissue being secured.

Referring to FIGS. 113 and 114, staple 1350, similar to staple 1340,includes crown 1302 and deformable legs 1344. Staple 1340, as describedabove, in at least one embodiment, is configured to compress tissuebetween deformable legs 1344 and crown 1302. However, in applications inwhich the tissue is very thin, for example, sufficient compression ofthe tissue between deformable legs 1344 and crown 1302 may be difficultto achieve and a gap between the tissue and legs 1344, for example, mayexist. For these applications, it may be desirable to include anadditional member intermediate the tissue and the deformable membersand/or crown which not only fills the gap, but compresses the tissueagainst at least one of the crown and/or deformable members.

Staple 1350, referring to FIGS. 113 and 114, can include, in variousembodiments, deformable, or compressible, member 1352. As describedabove, referring to FIG. 114, compressible member 1352 can bias tissue1353 against deformable legs 1344. As a result of this compression, thelumens, or vessels, in tissue 1353 can be compressed and thereby slowthe flow of blood therethrough. In at least one embodiment, compressiblemember 1352 is entirely elastic after it has been compressed, i.e., theaddition of, or the removal of, any stress onto compressible member 1352will result in a linearly corresponding increase, or decrease, in strainthereof. Stated in another way, in these elastic embodiments,compressible member 1352 can substantially act like a spring. However,in at least one embodiment, compressible member 1352 can be crushable,i.e., after it has been compressed, at least a portion, if not all, ofcompressible member 1352 is permanently deformed and the addition of, orremoval of, any stress onto compressible member 1352 does notnecessarily result in a linearly corresponding strain. In variousembodiments, compressible member 1352 can be comprised of foam. The foamcan be absorbable or non-absorbable. The foam can be comprised ofsynthetic materials and/or mammalian-derived materials including, butnot limited to, polyglycolide trimethylene carbonate copolymer,polyglycolic acid, caprolactone/glycolide, EPTFE, and bovinepericardium. Further, in at least one embodiment, compressible member1352 may include a first portion which is elastically deformable and asecond portion which is plastically deformable.

Referring to FIGS. 115 and 116, staple 1360 can include collapsiblespring member 1362. Collapsible spring member 1362 can include aplurality of first elastic members 1363 and second elastic members 1364.Each first elastic member 1363 can include an arcuate profile whichincludes projections 1365 extending therefrom which are sized andconfigured to contact corresponding projections 1366 extending from eachsecond elastic member 1364. More specifically, first elastic members1363 and second elastic members 1364 are configured such that they canbe stacked upon each other and, when a compressive load is applied tosuch a stack, the first and elastic members can flatten and thereby“collapse” the stack of elastic members. In the illustrated embodiment,collapsible spring member 1362 further includes fasteners 1367 and 1368.Referring to FIG. 115, fasteners 1367 can connect the central portionsof adjacent first elastic members 1363 and second elastic members 1364to prevent the elastic members from becoming dislodged or misalignedwith respect to each other. Similarly, fastener 1368 can preventcollapsible spring member 1362 from becoming dislodged with respect tocrown 1302. In use, collapsible spring member 1362 can provide acompressive load to tissue in between said deformable members and saidcrown.

Referring to FIGS. 117 and 118, staple 1370 can include cantileverspring 1372. Cantilever spring 1372 includes first end 1373 attached tocrown 1302 and second end 1374 which is free to move with respect tofirst end 1373. In use, when tissue is compressed between spring 1372and deformable legs 1344, spring 1372 can apply an upwardly-directedbiasing, or compressive, force against the tissue. More particularly, asdeformable legs 1344 are deformed and pushed against the tissue, secondend 1374 of spring 1372 can move downwardly with respect to first end1373. As a result of this deflection, spring member 1372 storespotential energy and acts to release this potential energy by applyingan upward force against the tissue, thereby compressing the tissuebetween spring member 1372 and deformable legs 1344. In an alternativeembodiment, referring to FIGS. 119-121, spring member 1382 of staple1380 can have first and second ends, 1382 and 1384, respectively,attached to crown 1302. In at least one embodiment, springs 1372 and1382, for example, can be integrally molded with crown 1302. In theseembodiments, springs 1372 and 1382 can be comprised of a dissolvable,bioabsorbable, or biofragmentable material such that, as the materialdissolves, the biasing force of springs 1372 and 1382 can decreasethroughout the healing process. As a result, a larger compressive forcecan be applied during the initial healing stages when the restriction ofblood loss is important and a smaller compressive force can be appliedduring the later healing stages when tissue regeneration is importantwherein the smaller force permits expansion and growth of the tissuewithin the staple.

In other various embodiments, although not illustrated, the tissue canbe positioned, and compressed between, the compressible member and thecrown of the staple. In these embodiments, the deformable members aredeformed against the compressible member which, as a result, iscompressed between the deformable legs and the tissue.

Referring to FIGS. 122 and 123, staple 1400 includes crown 1402, firstdeformable member 1404, and second deformable member 1406. Deformablemembers 1404 and 1406 each include a base 1408, a deformable leg 1410,and a second leg 1412 which, in the illustrated embodiment, arecomprised of a single continuous wire. In other various embodiments,staples 1400 may be configured in any other suitable manner to achievethe goals of the invention described herein. In the illustratedembodiment, members 1404 and 1406 are connected together by a materialthat is overmolded onto the bases 1408 of members 1404 and 1406. Invarious embodiments, the material can include a dissolvable,bioabsorbable, or biofragmentable material such as Vicryl and PDS fromEthicon, Inc., for example. As used herein, the terms dissolvable,bioabsorbable, and biofragmentable all generally refer to materials thatcan be at least partially assimilated by the body after being implantedinto a patient, for example.

In use, staple 1400 can be inserted into the soft tissue of a person,for example, via a stapler and can be deformed into the configurationillustrated in FIG. 124. More particularly, in the illustratedembodiment, deformable members 1404 and 1406 can be deformed by theanvil of the stapler such that ends 1411 of legs 1410 are brought intoclose proximity to crown 1402. Once staple 1400 is implanted into thetissue, crown 1402 may begin to break down, dissolve and weaken. Moreparticularly, referring to FIG. 125, the bioabsorbable material of crown1402 may deteriorate to the point where first member 1404 and seconddeformable member 1406 become disconnected from each other asillustrated in FIG. 126. Once first member 1404 and second member 1406have become disconnected, they can move relative to one another. Thetime required for crown 1402 to sufficiently dissolve may depend on thematerial used and/or the size of crown 1402. Polyglatin 910 material,sold under the tradename Vicryl, for example, may dissolve in 7-14 days.

In various embodiments, dissolvable crown 1402 may provide severaltherapeutic advantages. For example, when staple 1400 is initiallydeployed, deformable members 1404 and 1406 may significantly compressthe tissue within the staple against crown 1402. In some applications,this compression may be desirable to limit bleeding from the tissue. Ascrown 1402 deteriorates, the gap between the deformed members 1404 and1406 and crown 1402 may increase thereby relaxing the compressive forcesacting on the tissue. In some applications, relaxing the compressionforces during the healing process may allow the tissue to slowly expandand return to its normal thickness over a period of time. In someembodiments, crown 1402 can be coated with a hydrophilic material thatinitially expands to compress the tissue captured within the staplebefore dissolving away thereafter. In these embodiments, the hydrophilicmaterial expands by absorbing water from the surrounding tissue andfluids. In addition to the above, staple 1400, when it is inserted intothe tissue, may be very stiff and, if several staples are inserted intothe tissue, the tissue may not be permitted to move and expand duringthe healing process. However, after crowns 1402 of staples 1400 havedissolved, the deformable members 1404 and 1406 of the staples may beable to move relative to each other while still holding the underlyingtissue together.

In various embodiments, deformable members 1404 and 1406 may becomprised of a substantially non-dissolvable or non-bioabsorbablematerial. In other embodiments, at least one of deformable members 1404and 1406 may be comprised of a dissolvable, bioabsorbable, orbiofragmentable material such as magnesium or iron, for example. In atleast one embodiment, the iron is pure iron. In either event, thedissolvable material of members 1404 and 1406 can be selected such thatthey dissolve at the same rate as, slower than, or faster than thedissolvable material of crown 1402. For example, the material of crown1402 can be selected such that it completely dissolves away whiledeformable members 1404 and 1406 are still holding tissue together.Further, in various embodiments, the material of first deformable member1404 can be selected such that it dissolves faster than the material ofsecond deformable member 1406. Accordingly, the deformable members ofthese embodiments may allow for a staggered release of the tissue.Further, in various embodiments, at least two adjacent staples 1400, asdescribed in greater detail below, can be connected by a bridge beforeand/or after the staples have been deployed into the tissue. In theseembodiments, a first staple can be comprised of bioabsorbable materialsthat dissolve away at a faster rate than the materials of a secondstaple attached thereto. Similarly, the bridge connecting the staplescan be comprised of materials that dissolve away at the same rate,and/or a different rate, than the first and second staples. In theseembodiments, the first staples can dissolve away before the secondstaples allowing for a staggered release of the tissue.

The staples described above can be used to approximate tissue, i.e., thestaples can secure resected or damaged tissue such that the strength ofthe resected or damaged tissue approximates that of healthy tissue. Tothis end, a method of approximating tissue can include suturing tissuewith a surgical staple comprised of a dissolvable material and anon-dissolvable material to approximate tissue in a first state, anddissolving the dissolvable material to cause the remainingnon-dissolvable material to approximate the tissue in a second state. Inat least one embodiment, the tissue approximation in the second state ismore flexible than in the first state.

In addition to the above, referring to FIG. 132, crown 1402 may becomprised of at least two overmolded or co-molded materials. Moreparticularly, crown 1402 may be comprised of a first material 1435overmolded onto deformable members 1404 and 1406 and a second material1436 overmolded onto second material 1436, for example. In thisembodiment, second material 1436 can be configured to dissolve awayquickly thereby allowing deformable members 1404 and 1406 to separatefrom each other early on in the healing process. However, first material1435 can be selected to dissolve at a slower rate than second material1436 in order for crown 1302 to continue to provide a compressive forceon the tissue even after second material 1436 has completely dissolvedaway. In at least one embodiment, first material 1435 can be injectionmolded onto deformable members 1404 and 1406 and then permitted to cure,and/or substantially solidify, before second material 1436 is injectionmolded onto first material 1435. In other various embodiments, firstmaterial 1435 and second material 1436 can be injection molded ontodeformable members 1404 and 1406 at substantially the same time or inrapid succession. In these embodiments, the first and second materialscan chemically bond together to provide sufficient strength therebetweenso that the staple may be handled without the first and second materialsseparating from one another. In other embodiments, the first and secondmaterials can form mechanically interlocking features to accomplish thesame result.

In the embodiment illustrated in FIG. 123, crown 1402 may includereduced cross-section 1414 intermediate portions 1416 and 1418. In use,intermediate section 1414, as it has a smaller cross-section thanportions 1416 and 1418, may completely dissolve away before sections1416 and 1418 thereby allowing first member 1404 to become unconnectedfrom second member 1406 before the entirety of crown 1402 has dissolved(FIG. 125). In at least one embodiment, the cross-sections of sections1414, 1416, and 1418 can be selected such that deformable members 1404and 1406 become unconnected at a desired stage in the healing process.In at least one embodiment, referring to FIG. 133, crown 1402 caninclude score marks 1437 which reduce the thickness of crown 1402 in thescored areas. In these embodiments, the score marks may be formed whencrowns 1402 are overmolded onto deformable members 1404 and 1406 orformed by a cutting tool thereafter. As a result of score marks 1437,crown 1402, as it dissolves, can break up into several small pieceswhich are, in some circumstances, more easily absorbable by the body. Inat least one embodiment, referring to FIG. 134, crown 1402 may include aplurality of pockets 1438 intermediate raised portions 1439. In use, thematerial intermediate raised portions 1439 may dissolve away leavingbehind a lattice, or grid, of raised portions 1439 intermediatedeformable members 1404 and 1406.

In at least one embodiment, crown 1402 is also comprised of at least onetherapeutic drug. In these embodiments, as the dissolvable materialdeteriorates, the therapeutic drug can be absorbed by the surroundingtissue. In some embodiments, the drug is dispersed throughout thedissolvable material such that the drug is steadily released during thehealing process, however, in other embodiments, the therapeutic drug maybe unevenly dispersed throughout the dissolvable material, or layeredwithin and/or on the material to provide an increased dosage of the drugat a particular stage in the healing process.

In at least one embodiment, having an absorbable staple with anabsorbable insulator reduces the possibility of arcing along a row ofstaples when an electrocautery device is used in situ, for example. Theabsorbable insulators, or crowns, on the staples substantially preventan electrical current from jumping between staples as the top of eachstaple is not electrically conductive under normal operating conditions.As a result, the possibility of damaging tissue is reduced.

In use, as described above, and referring to FIGS. 127 and 128,deformable members 1404 and 1406 of staple 1400 are deformed by anvil1420 of stapler 1422. More particularly, ends 1411 of members 1404 and1406 are received within recesses 1424 in anvil 1420 and are guidedtoward crown 1402 as members 1404 and 1406 are deformed by anvil 1420.Referring to FIGS. 129 and 129A, recesses 1424 can include aconfiguration which causes the ends of members 1404 and 1406 to bend outof plane with members 1412 and bases 1408. More particularly, referringto FIGS. 130 and 131, each recess 1424 includes several planar surfacesoriented to initially deflect end 1411 laterally, and then downwardly,to curl the top portion of deformable leg 1410 alongside the bottomportion of deformable leg 1410 as illustrated in FIG. 131. Referring toFIGS. 130 and 131, recess 1424 includes surfaces 1426 and 1428 whichform vertex 1430 therebetween. Surfaces 1426 and 1428, and vertex 1430,are configured to receive end 1411 of deformable member 1406, forexample. After sufficient pressure is applied by anvil 1420, leg 1410 ofdeformable member 1406 is curled within vertex 1430. Thereafter, as leg1410 is further deformed, leg 1410 also contacts vertex 1432 which isintermediate surfaces 1428 and 1434 of recess 1424. As illustrated inFIG. 131, vertex 1432 assists in deforming member 1406 into a desiredshape. While the above anvils are described in connection with staples1400, these anvils can be used to deform other differently-configuredstaples including the suitable staples disclosed in this application.

Referring to FIGS. 96 and 97, staple 1300 includes an integral staplecrown and driver. More particularly, referring to FIG. 105, crown 1302is configured to be directly driven by cam sled 78. In use, as describedin detail above, cam sled 78 is progressed through staple cartridge 1326from the position illustrated in FIG. 105 toward distal end 1327 ofstaple cartridge 1326. As cam sled 78 is moved in this direction,staples 1300 are successively lifted by cam sled 78 toward anvil 1316.In previous surgical staplers, a separate driver was positionedintermediate the cam sled and the staple. However, the present inventionsimplifies these previous systems by including features in crown 1302which allow staples 1300 to be directly lifted by cam sled 78. Moreparticularly, referring to FIGS. 96 and 97, crown 1302 includes beveledsurfaces 1328 which are configured to co-operate with angled surface1330 of cam sled 78 such that crowns 1302 slide up cam surface 1330. Inthe illustrated embodiment, both beveled surfaces 1328 and cam surface1330 are oriented at an approximately 30 degree angle with respect tothe horizontal. As a result, in the present embodiment, beveled surface1328 may sit flushly on cam surface 1330, however, embodiments areenvisioned in which beveled surfaces 1328 and cam surface 1330 are notoriented at the same angle. Furthermore, the present invention is notlimited to embodiments having 30 degree angles. On the contrary, anysuitable angle, or angles, can be used.

Referring to FIGS. 96 and 97, base 1301 of staple 1300, in theillustrated embodiment, is embedded in crown 1302. More particularly,crown 1302 can be overmolded onto base 1301 such that crown 1302 tightlysurrounds base 1301 and wherein, in the present embodiment, base 1301 isenveloped or enclosed by crown 1302. In other various embodiments, crown1302 may be separately manufactured and then assembled to base 1301. Ineither event, base 1301 and/or deformable members 1304 and 1306 can beat least partially embedded into crown-driver 1302. As a result, staple1300 can include larger deformable members 1304 and 1306 than inprevious designs. In these embodiments, as a result of the above, staple1300 may accommodate larger tissues intermediate the deformable membersand tissue-contacting surface 1336 of crown 1302. In one embodiment,crown-driver 1302 may be comprised of a dissolvable or bioabsorbablematerial, as described above, that, as it dissolves, allows the tissuecompressed within staple 1300 to expand and grow. In variousembodiments, as described above, crown-driver 1302 may be comprised of,or coated by, a hydrophilic material that expands when exposed to waterin the body to further compress the tissue in the staple. Further,similar to the above, crown-driver 1302 may be configured to increasethe contact area between crown 1302 and the tissue. In some embodiments,increasing this contact area reduces the localized stress on the tissuesurface which may reduce the possibility of tissue necrosis, forexample.

As indicated above, an integral staple crown and driver may reduce thequantity of components needed to deploy the staples. As a result,embodiments in accordance with the present invention may reduce the costand/or manufacturing time to produce the stapling systems. Further,eliminating the separate driver components may reduce the possibility ofmisalignment between the staples and the cam sled.

In an alternative embodiment of the present invention, referring to FIG.135, staples 1450 can each include a crown 1451 and two deformable legs1452 extending therefrom. Referring to FIG. 135, the crowns of staples1450 can be connected together by bridge 1455. Similar to the above,crowns 1451 and bridge 1455 can be integrally molded onto staple legs1452. Also similar to the above, crowns 1451 can include beveledsurfaces 1453 which, referring to FIG. 139, can be configured tocooperate with angled surface 1454 of cam driver 1462. As above, camdriver 1462 is configured to successively raise staples 1450 toward ananvil positioned opposite deck 1456 of staple cartridge 1457. Asdiscussed in greater detail below, bridges 1455 can be configured toconnect staples 1450 even after they have been deployed or,alternatively, staple cartridge 1457 can include shears which breakbridges 1455 and separate staples 1450 when they are deployed.

Staple cartridge 1457, referring to FIGS. 136-138, further includescavities 1458 configured to receive staples 1450. In at least oneembodiment, cavities 1458 include keys 1459 which are sized andconfigured to fit within slots 1460 in crowns 1451. More particularly,slots 1460 and keys 1459, in the present embodiment, are configured tosubstantially limit the motion of staples 1450 with respect to staplecartridge 1457 to a substantially linear motion, i.e., in the presentembodiment, an upwardly and/or downwardly motion. As a result of thesefeatures, the possibility of staples 1450 becoming bound within ormisaligned with respect to cavities 1458 can be reduced. In alternativeembodiments, cavities 1458 can include slots and staples 1450 can havekeys.

Although surfaces 1453 have been described herein as being beveled,surfaces 1453 are not limited to flat surfaces. On the contrary, variousembodiments are envisioned in which surfaces 1453 are curved, radiused,curvilinear, and/or include several sections having variousconfigurations. In either event, surfaces 1453 are configured toco-operate with cam sled 1462 such that staples 1450 are deployed asdescribed above. Similarly, surface 1454 of cam sled 1462 is not limitedto a flat surface. On the contrary, surface 1454 can be curved,radiused, curvilinear, and/or have any other suitable configuration.

Staple cartridge 1500, referring to FIG. 140, includes recesses 1502 forreceiving staple strips 1504. Referring to FIGS. 140 and 141, staplestrips 1504 include several staples 1506 connected together by bridges1508. Recesses 1502 include several pockets 1510 which are sized andconfigured for receiving staples 1506 therein. In at least oneembodiment, staples 1506 include deformable members 1512 which are sizedand configured to be biased against the sidewalls of notches 1514 inrecesses 1502. More particularly, deformable members 1512 can beconfigured to create a press-fit between staples 1506 and pockets 1510such that staple strips 1504 remain seated within recesses 1502 undernormal usage conditions. However, in the present embodiment, staplestrips 1504 can be removed from recesses 1502 with a moderateapplication of force.

As illustrated in FIG. 140, recesses 1502 open to top surface 1516 ofstaple cartridge 1500 such that staple strips 1504 can be inserted intostaple cartridge 1500 by aligning strips 1504 with recesses 1502 in topsurface 1516 and pressing them into the position illustrated in FIG.141. Referring to FIG. 141, recesses 1502 further include recessportions 1518 intermediate adjacent pockets 1510 which are sized andconfigured for receiving bridges 1508. In the embodiment illustrated inFIGS. 140-143, bridges 1508 are configured such that adjacent staples1506 can move with respect to each other when being inserted intopockets 1510. Accordingly, bridges 1508 can accommodate dimensionaldifferences, and/or manufacturing tolerances, in the alignment of strips1504 with recesses 1502. More particularly, each bridge 1508 can includea curved portion 1520 configured to allow portions 1522 of bridge 1508to move with respect to each other.

In the illustrated embodiments, the deformable members of each staple1506 comprise a single continuous wire that can be bent into a “U”and/or “V” shape. Crowns 1513, in the present embodiment, can beovermolded onto a portion of these wires such that the wires areembedded into and supported by crown 1513. In addition, as illustratedin FIG. 143, bridges 1508 can be integrally molded with crowns 1513 whencrowns 1513 are overmolded onto the wire. As a result, bridges 1508 andcrowns 1513, in the present embodiment, can comprise an integral,continuous body of plastic, for example. Although not illustrated,bridges 1508 and crowns 1513, in various embodiments, may be molded as aseparate component, or components, that are attached to the staples. Inthese embodiments, the wires of the staples can be press-fit and/orglued into recesses in the separately molded components, for example.

In use, referring to FIG. 144, as sled 78 is moved forward, sled 78lifts staples 1506 upwardly toward an anvil positioned opposite topsurface 1516. Owing to the angled orientation of surface 1523 of sled78, staples 1506 a-1506 e, for example, are incrementally lifted insuccessive order. More particularly, staples 1506 a and 1506 b, whilethey are being lifted by sled 78, may be lifted to different relativeheights with respect to surface 1516 at any given moment. To accommodatethis difference in relative position, bridge 1508 a can be flexible suchthat it does not break as staple 1506 a is being deployed. Bridge 1508a, in the embodiment illustrated in FIG. 144, can be configured suchthat it remains attached to staples 1506 a and 1506 b during thedeployment thereof and, in addition, during the initial healing processof the patient.

In other various embodiments, referring to FIGS. 145-147, staples 1506can be connected together by bridges 1526 to form staple strips 1528.Similar to bridges 1508, bridges 1526 can be integrally formed withcrowns 1513 when crowns 1513 are overmolded onto deformable members 1512as described above. However, bridges 1526, unlike bridges 1508, can beconfigured such that they break away from at least one of the twoadjacent staples 1506 that they connect. More particularly, referring toFIGS. 146 and 147, bridges 1526 can include notches 1530 therein whichare configured to reduce the cross-sectional thickness, and strength, ofbridges 1526. In use, referring to FIG. 147, as staple 1506 a is liftedupwardly with respect to staple 1506 b, bridge 1526 a can break awayfrom staple 1506 a. Stated another way, when staple is 1506 a is liftedupwardly, the stress created within bridge 1526 a by pulling staple 1506a away from staple 1506 b may cause bridge 1526 a to break, especiallyin the portion of bridge 1526 a having notch 1530 therein.

In the illustrated embodiment, bridge 1526 a may remain attached tostaple 1506 b after it has been deployed. In other embodiments, bridge1526 a may remain attached to staple 1506 a. In either event, notches1530 can be designed such that bridges 1526 remain attached to a desiredstaple. In other embodiments, bridges 1526 may separate from bothadjacent staples 1506 and fall into a cavity (not illustrated) withinstaple cartridge 1500, and/or sled 78. In these embodiments, theseparated bridges 1526 may be removed from the stapler by removing thestaple cartridge and/or removing them through an access panel in eitherthe staple cartridge and/or the sled. In various embodiments, notches1530 are not included in every bridge 1526. In these embodiments,several staples may remain attached to each other after being deployedwhile other staples may be detached. In these embodiments, the stiffnessof the row of staples, when inserted into the tissue, can be controlledby selectively alternating whether the staples are attached or detached.

Referring to FIG. 146, bridges 1526 may include a substantially flat topsurface 1532 which is substantially flush with top surfaces of crowns1513. Bridges 1526 may further include a substantially arcuate surface,or lobe, 1534 in the bottom of bridges 1526 such that the thickestportions of bridges 1526 are adjacent to staples 1506. As a result ofthis configuration, the overall deflection of staple strip 1528 may bereduced making staple strip 1528 easier to insert into the staplecartridge. In other embodiments, referring to FIGS. 148-150, bridges1536 may have lobes 1534 which face upward, i.e., in the oppositedirection that they face on bridges 1526. In lieu of the configurationsof bridges 1526 and 1536 which have a flat surface 1532, the bridges maycomprise an arcuate configuration on both sides of the bridge. In theseembodiments, similar to the embodiment in FIGS. 142 and 143, the bridgesmay deflect to permit some relative movement between adjacent staples1506.

In various other embodiments, referring to FIGS. 151-157, the staplestrips may be loaded into the staple cartridge from the bottom of thestaple cartridge. For example, referring to FIGS. 155-157, staplecartridge 1550 includes cavities 1552 and 1554 which are sized andconfigured for receiving staple strips 1540 and 1542, respectively. Inuse, staple strips 1540 and 1542 are aligned with openings 1555 and 1557in bottom surface 1551 and are inserted into cavities 1552 and 1554,respectively. In various embodiments, staple strips 1540 and 1542 may beconfigured such that they are press fit into cavities 1552 and 1554. Inthese embodiments, similar to the above, deformable members 1512 couldengage the sidewalls of the cavities to retain staple strips 1540 and1542 in staple cartridge 1550. In various embodiments, crowns 1513and/or bridges 1538 of staple strips 1540 and 1542 can be dimensionedsuch that they engage the sidewalls of cavities 1552 and 1554 in afriction-fit manner. In other embodiments, staple cartridge 1550 andstaple strips 1540 and 1542 may include co-operating detent featureswhich retain the staple strips in the staple cartridge. Once insertedinto the cavities, staples 1541 of staple strips 1540 and 1542 can bepositioned such that a portion of their deformable members 1512 extendthrough openings 1559 and 1561 in top surface 1553. Deformable members1512 of staples 1541, as illustrated in FIG. 151, can extendsubstantially perpendicularly from crowns 1513.

Similar to the above, referring to FIGS. 155 and 156, staple strips 1540and 1542 can be advanced upward through cavities 1552 and 1554 toward ananvil positioned opposite top surface 1553 from a first positionillustrated in FIG. 155 to a second position illustrated in FIG. 156.When staple strips 1540 and 1542 are advanced into the positionillustrated in FIG. 153, bridges 1538 may be pressed against shears 1560of staple cartridge 1550. Thereafter, the staple strips may be pushedfurther upward causing shears 1560 to break bridges 1538 away from oneor more of staples 1541, as described above. Referring to FIG. 154,shears 1560 in cavity 1552 include projections 1562 which extendtherefrom and are configured to break bridges 1538 away from crowns 1531at locations 1564 (FIG. 151).

In any of the embodiments described herein, the material overmolded ontothe staples to form crowns 1513 and bridges 1526, and/or bridges 1508,may be comprised of a dissolvable, bioabsorbable or biofragmentablematerial. Further, similar to the above, in various embodiments, thebioabsorbable material may include at least one therapeutic drug mixedtherein or coated thereon, for example. Similar to the above, in variousembodiments, drivers may be connected to, and/or integrally molded with,the crowns of the staples.

In alternative embodiments, the staples may be connected in “puck”configurations in lieu of strips, for example. In various embodiments,referring to FIG. 158, staple pucks 1571 and 1572 include staples 1506which are interconnected by bridges 1574 and 1575. Staple pucks 1571have five staples 1506 which are interconnected by two bridges 1574 andtwo bridges 1575. As illustrated in FIG. 158, bridges 1575 connectadjacent staples 1506 such that the tops of their crowns 1513 aresubstantially flush with each other, however, bridges 1574 connectadjacent staples 1506 such that the top of their crowns 1513 arevertically offset from each other. Similarly, staple pucks 1572 includefour staples 1506 which are interconnected by two bridges 1574 and twobridges 1575.

Referring to FIGS. 159 and 159A, staple cartridge 1576 includes cavities1577 which are sized and configured for receiving staple pucks 1571, andcavities 1578 which are sized and configured for receiving staple pucks1572. Referring to FIG. 160, staple cartridge 1576 further includesdrivers 1579 and 1580 which are sized and configured for supportingstaple pucks 1571 and 1572, respectively, thereon. More specifically,referring to FIGS. 161-163, drivers 1579 and 1580 can include shears1581 upon which staples pucks 1571 and 1572 are supported. After beinginserted into cavities 1577 and 1578, referring to FIG. 163, bridges1574 and 1575 are positioned over shears 1581. In use, as describedabove, drivers 1579 and 1580 are lifted toward deck 1582 of staplecartridge 1576 by a cam sled. However, referring to FIG. 163, oncedrivers 1579 and 1580 contact bridges 1574 and 1575, and the upwardmovement of staple pucks 1571 and 1572 is prohibited by staple cartridge1576, further upward movement of drivers 1579 and 1580 causes shears1581 to break bridges 1574 and 1575, thereby separating staples 1306.Once bridges 1574 and 1575 have been broken, support surfaces 1582 ofdrivers 1579 and 1580 are configured to push staples 1306 upwardlytoward an anvil, as described above. Referring to FIGS. 164 and 164A, analternative staple cartridge 1583 is illustrated having recesses sizedand configured for receiving alternate configurations of the staplepucks.

In at least one alternative embodiment of the present invention,referring to FIGS. 165 and 166, staple pucks 1584 and 1585 can beconfigured such that bridges 1586 interconnecting staples 1587, forexample, include shears 1588 extending therefrom. In the presentembodiment, referring to FIG. 167, shears 1588 can be configured todissect deck 1589 of staple cartridge 1590. More particularly, as staplepucks 1585 are raised by cam sled 1591, for example, shears 1588 canbreak through deck 1589 such that pucks 1585 can be raised above deck1589 when deployed. As a result, staples 1587 can be completely deployedfrom staple cartridge 1590 before staple cartridge 1590 is removed fromthe surgical site. In alternative embodiments, although not illustrated,the staple cartridge can also include shears which detach staples 1587from bridges 1586, and/or shears 1588, after shears 1588 have dissectedstaple cartridge deck 1589. Similar to the above, bridges 1589 caninclude beveled surfaces 1592 which are configured to co-operate withcam sled 1591.

Referring to FIG. 168, staples 1465 can each include a first deformableleg 1466, a second deformable leg 1467, and a base 1468 connectingdeformable legs 1466 and 1467. Unlike previous staples which have a basethat is substantially co-planar with its legs, base 1468 can extend inat least one direction that is transverse to a plane defined by legs1466 and 1467. More particularly, base 1468 can include first portion1469 and second portion 1470 which extend laterally from legs 1466 and1467 and form an angle therebetween. In the present embodiment,referring to FIG. 169, first portion 1469 forms an approximately 90degree angle with respect to second portion 1470. However, the presentinvention is not limited to 90 degree angles; rather, any suitable anglemay be used. More particularly, the angle between first portion 1469 andsecond portion 1470 may, in some embodiments, be greater than 90 degreesand may, in other embodiments, be less than 90 degrees. Furthermore, inother embodiments, base 1468 may include several substantially linearsegments and/or curved sections.

Staple 1465 can further include crown 1471 overmolded onto base 1468.More particularly, owing to the configuration of base 1468 as describedabove, crown 1471 can also extend transversely with respect to the planedefined between legs 1466 and 1467. Referring to FIGS. 168 and 169,crown 1471 can include tissue-contacting surface 1472 which is sized andconfigured for supporting tissue thereon. Tissue-contacting surface1472, owing to the configuration of crown 1471, can be larger than thetissue contacting surfaces of previous staples. Accordingly, the largercontact surface can reduce the localized pressure acting on the tissuecaptured within the staple. As known in the art, reducing this localizedpressure can reduce the possibility of tissue necrosis without reducingthe compressive force acting on the tissue. Stated another way, thepressure acting on the tissue is a function of the force acting on thetissue divided by the area in which it acts. Increasing the area canreduce the localized pressure while not reducing the clamping forceapplied by the staple.

Further, owing to the configurations of base 1468 and crown 1471, thelarger surface area of crown 1471 can improve the stability of crown1471, and the surrounding tissue, after the staple has been deployedinto the tissue. More particularly, after previous staples are deployed,the relatively-narrow crowns of these previous staples may not preventthe staples from rocking with respect to the tissue or straining thetissue surrounding the staple. Staples 1465, owing to the configurationof crown 1471, can reduce, and possibly eliminate, these previousproblems. More specifically, owing to larger contact surface 1472, crown1471 is more stable, i.e., it is less likely to rotate with respect tothe tissue. Furthermore, the crowns of previous staples, owing to theirnarrower configurations, may cut through the underlying tissue. Staple1465, owing to the larger configuration of crown 1471, may reduce, oreven eliminate, this possibility. In an alternative embodiment,referring to FIG. 173, staple assembly 1479 can include several of the“J” deformable members of staple 1400 (FIGS. 122 and 123).

To further improve the stability of staples 1465, two adjacent staples1465, for example, may be connected together by bridge 1473. Morespecifically, referring to FIGS. 168 and 169, the base 1468, and crown1471, of the first staple may be laterally disposed in one direction andthe base 1468, and crown 1471, of the second staple may be laterallydisposed in the opposite direction. These oppositely disposed featuresmay improve the stability of the staples by providing stabilizingsurfaces on opposite sides of the assembly. The two staples, referringto FIG. 172, may be deployed from staple cartridge 1475 by cam sled 1474at the same time. To facilitate the deployment of the staples, staplecartridge 1475 may include, similar to the above, slots 1476 sized andconfigured for receiving keys 1477 extending from crowns 1471 of staples1465. More particularly, keys 1477 and slots 1476 can be configured tolimit the movement of staples 1465 with respect to staple cartridge 1475to a substantially linear upward motion. In addition, similar to theabove, each bridge 1473 can include an integral driver 1478 which isconfigured to co-operate with cam sled 1474. In at least one embodiment,crowns 1471, bridge 1473 and driver 1478 can be comprised of adissolvable or bioabsorbable material.

As known in the art, staples can be deployed into tissue such thatstaples are aligned in a row. However, in the past, staples configuredin diagonal patterns have been disincentivized owing to potential leakpaths between the staples. The staples of the present invention canovercome these previous problems. Referring to FIGS. 174 and 175,staples 1480 each include two deformable members 1481 extending from acrown 1482 and bridge 1483 connecting crowns 1482. When staples 1480 areinserted into tissue, as described above, the tissue is compressedbetween crowns 1482 and deformable members 1481. However, in theembodiments in which bridges 1483 are inserted into the body along withstaples 1480, bridges 1483 can also compress the tissue and close offany leak paths therebetween. Referring to FIG. 175, staple cartridge1484 includes recesses 1485 therein which are configured to receivestaples 1480 in a diagonal pattern such that staples 1480 can bedeployed into the tissue as described above.

In an alternative embodiment, a portion of the staple cartridge can bebroken away therefrom during the deployment of the staple. This portioncan be configured to be positioned intermediate the base of the stapleand the tissue captured within the staple. More particularly, referringto FIGS. 176-178, a surgical stapling system can include staplecartridge 1486 having staple pads 1487 integrally molded into deck 1488of staple cartridge 1486. Staple cartridge 1486 can include score marks1489 and slots 1490 surrounding staple pads 1487 such that staple pads1487 can be easily separated from deck 1488. More particularly,referring to FIG. 178, the stapling system can include drivers 1491having shears 1492 which are configured to press against staple pads1487 when base 1493 is brought in close proximity to staple saddle 1494and “punch-out” staple pads 1487. In at least one embodiment, after theyhave been punched out, the staple pads can be positioned intermediatebase 1493 and the tissue captured within the staple. As a result, staplepads 1487 can be configured to act as the crown of the staple or, inalternative embodiments, act as a buttressing member intermediate thestaple and the tissue. In at least one embodiment, similar to the above,staple pads 1487 can be comprised of a bioabsorbable material.

The staples described above can be used in various surgical techniques.For example, one surgical technique can include a method of transectingtissue or a hollow organ by positioning a surgical stapling systemadjacent tissues to be transected, the surgical stapling systemincluding at least one of the staples described above, actuating thesurgical stapling system to compress the tissues together, actuating thesurgical stapling system to fasten and divide the tissue with saidstaple, and removing the surgical stapling system from the operativesite. In at least one embodiment, the surgical technique can include theanastomosis of two hollow organs and/or the fixation of at least twotissues.

Referring to FIG. 179, a surgical stapling instrument, generally 3100,can comprise a first handle portion 3102 and a second handle portion3104. In various embodiments, first handle portion 3102 and secondhandle portion 3104 can be configured to be grasped by a surgeon, forexample, and can comprise hand grip portion 3106. In at least oneembodiment, first handle portion 3102, referring to FIGS. 180 and 181,can include a first cover 3108 attached to a first frame 3110 and,similarly, second handle portion 3104 can include a second cover 31112attached to a second frame 3114. Covers 3108 and 31112 can beergonomically contoured, or otherwise suitably contoured, to assist asurgeon in manipulating stapling instrument 3100 within a surgical site.In various embodiments, handle covers 3108 and 3112, for example, caninclude enlarged protrusions 3109 and 3113, respectively, which canfacilitate the insertion of stapling instrument 3100 into a surgicalsite. In various embodiments, handle covers 3108 and 3112 can be made ofplastic, lightweight materials, and/or any other suitable material, forexample, while handle frames 3110 and 3114 can be made of stainlesssteel, titanium, and/or any other suitable material, for example.

In various embodiments, referring again to FIGS. 179-181, the distalends of handle portions 3102 and 3104 can comprise an end-effector 3120which can be configured to treat tissue within a surgical site, forexample. In at least one such embodiment, end-effector 3120 can includea staple cartridge channel 3122 configured to receive and/or retain astaple cartridge as described in greater detail further below. Incertain embodiments, staple cartridge channel 3122 can comprise aone-piece elongated channel-shaped frame extending from first handleportion frame 3110. In at least one embodiment, staple cartridge channel3122 can include a pair of opposed, elongated side walls 3124 connectedby a bottom wall 3126. Along the rearward, or proximal, portion ofstaple cartridge channel 3122, a pair of spaced, upstanding side flanges3128 can extend upwardly from opposed side walls 3124. In variousembodiments, the width of staple cartridge channel 3122 between sideflanges 3128 can be greater than the width of the upper jaw member, oranvil, 3130 extending from second handle portion 3104. In at least oneembodiment, the distance between flanges 3128 can be configured topermit at least a portion of anvil 3130 to be received between sideflanges 3128 when the stapling instrument is assembled for operation. Asshown in FIG. 180, each side flange 3128 of can include a notch, orrecess, 3127, for example, which can be configured to receive one ormore latch projections 3131, for example, extending from anvil 3130,and/or any other suitable portion of second handle portion 3104, asdescribed in greater detail further below.

As indicated above, referring once again to FIGS. 179-181, staplecartridge channel 3122 can be configured to support and/or retain astaple cartridge, such as staple cartridge 3150, for example, withinend-effector 3120, wherein the staple cartridge can include one or morestaples (not illustrated) removably stored therein. In variousembodiments, referring to FIGS. 186-188, staple cartridge 3150 caninclude one or more staple cavities 3151 which can be configured tostore staples in any suitable arrangement, such as in at least twolaterally-spaced longitudinal rows, for example. In at least oneembodiment, referring to FIGS. 187 and 188, staple cartridge 3150 caninclude staple cartridge body 3152 and pan 3154, wherein staplecartridge body 3152 and/or pan 3154 can be configured to define achannel, or path, for slidably receiving a staple sled and/or cuttingmember therein. In at least one embodiment, pan 3154 can includeflexible arms 3155, for example, which can be configured to engagestaple cartridge body 3152 in a snap-fit and/or press-fit arrangement.Referring to FIGS. 188-190, staple cartridge 3150 can further includestaple sled assembly 3160 which can include staple sled portion 3162and, in addition, cutting member 3164. In various embodiments, cuttingmember 3164 can include cutting edge 3165 and lock arm 3166, forexample, wherein lock arm 3166 can be configured to be press-fit and/orsnap-fit into aperture 3163 in staple sled 3162 when cutting member 3164is assembled to staple sled portion 3162. In other various embodiments,staple sled portion 3162 can be integrally molded to cutting member3164.

Further to the above, referring to FIGS. 186-188, staple cartridge body3152 can include a slot, such as slot 3156, for example, which can beconfigured to receive at least a portion of cutting member 3164 therein,and/or any other portion of staple sled assembly 3160 and pusher barassembly 3200 (discussed below), wherein slot 3156 can be configured topermit cutting member 3164 to be moved between first and secondpositions within staple cartridge 3150. In various embodiments, slot3156 can be configured to permit cutting member 3164 to be moved betweena proximal position (FIG. 188) and a distal position in order to incisetissue positioned intermediate staple cartridge 3150 and anvil 3130, forexample. Referring again to FIGS. 188-190, staple sled portion 3162 caninclude cam, ramp, or actuator, surfaces 3167 which can be configured toengage staple drivers positioned within staple cartridge 3150. Invarious embodiments, referring to FIG. 187, staple cartridge 3150 caninclude staple drivers 3168 which can be lifted, or slid, upwardlywithin staple cavities 3151 by sled portion 3162 such that the upwardmovement of staple drivers 3168 can eject, or deploy, staples at leastpartially positioned within staple cavities 3151. While staple drivers3168 can be, in fact, lifted vertically upwardly, the term upward, andthe like, can mean that staple drivers 3168, for example, are movedtoward the top surface, or deck, 3158 of the staple cartridge and/ortoward anvil 3130, for example. In certain embodiments, as illustratedin FIG. 187, each staple driver 3168 can include one or more slopedsurfaces 3169 oriented at the same angle as a cam surface 3167, and/orany other suitable angle, which can provide a relatively flat, or atleast substantially flat, sliding contact surface between staple sled3162 and staple drivers 3168. In various embodiments, a staple drivercan be configured to deploy only one staple, while, in certainembodiments, a staple driver can be configured to simultaneously deploytwo or more staples located in adjacent rows, for example. Other devicesare disclosed in U.S. patent application Ser. No. 12/030,424, entitledSURGICAL STAPLING INSTRUMENT WITH IMPROVED FIRING TRIGGER ARRANGEMENT,which was filed on Feb. 13, 2008, now U.S. Pat. No. 7,766,209, theentire disclosure of which is incorporated by reference herein.

In various embodiments, as described above, a surgical staplinginstrument can include a cutting member/staple sled assembly configuredto incise tissue and deploy staples from a staple cartridge. In certainembodiments, though, a surgical stapling instrument may not require, orinclude, a cutting member. In at least one such embodiment, a staplecartridge can include a staple sled positioned therein and/or a surgicalinstrument can be configured to move a staple sled into a staplecartridge in order to staple tissue, for example, without otherwisedissecting it. In certain other embodiments, a staple cartridge caninclude a staple sled positioned therein where a surgical instrument caninclude a cutting member movable into, or relative to, the staplecartridge. In at least one such embodiment, the cutting member can beadvanced into contact with the staple sled such that the cutting memberand staple sled can be advanced together. Thereafter, the cutting membercan be sufficiently retracted to allow the staple cartridge to bedetached from the surgical instrument and replaced with a new staplecartridge having a new staple sled. Such embodiments may be useful whena staple sled may become worn or deformed during use. Other embodimentsare envisioned where a staple cartridge can include a cutting memberpositioned therein where a surgical instrument can include a staple sledmovable into, or relative to, the staple cartridge. In at least one suchembodiment, similar to the above, the staple sled can be advanced intocontact with the cutting member such that the cutting member and staplesled can be advanced together. Thereafter, the staple sled can besufficiently retracted to allow the staple cartridge to be detached fromthe surgical instrument and replaced with a new staple cartridge havinga new cutting member. Such embodiments may be useful when a cuttingmember may become worn or deformed during use. In various embodiments,as described in greater detail below, the staple cartridge can include aprotective housing or cover configured to prevent, or at least reducethe possibility of, a surgeon or other clinician from touching thecutting member positioned within the staple cartridge while handling thestaple cartridge, for example.

In various embodiments, further to the above, staple cartridge channel3122 and/or staple cartridge 3150, for example, can include one or moreco-operating projections and/or recesses, for example, which can beconfigured to removably retain staple cartridge 3150 within staplecartridge channel 3122. Once staple cartridge 3150 has been insertedinto staple cartridge channel 3122, in various embodiments, the firsthandle portion 3102 can be assembled to the second handle portion 3104.In other various embodiments, the staple cartridge may be inserted intothe staple cartridge channel after the first and second handle portionshave been assembled together. In either event, referring to FIGS.179-185, first handle portion 3102 and second handle portion 3104 caninclude proximal ends 3103 and 3105, respectively, which can beassembled together such that the first and second handle portions can berotatably or pivotably coupled to one another. In various embodiments,referring to FIGS. 180 and 181, first handle portion 3102 can includeone or more pins, or projections, 3111 extending therefrom which can beconfigured to be slidably received within one or more grooves, channels,or slots 3115 in second handle portion 3104. In certain embodiments,slots 3115 can be defined in second handle frame 3114 and projections3111 can extend from a proximal end post 3107 extending from firsthandle frame 3110, for example. In order to assemble first handleportion 3102 and second handle portion 3104, referring to FIG. 182, theopen ends of slots 3115 can be aligned with projections 3111 such thatsecond handle portion 3104, for example, can be translated relative tofirst handle portion 3102 and projections 3111 can be slid within slots3115. In at least one embodiment, as illustrated in FIGS. 180 and 181,the open ends of slots 3115 can be located proximally with respect totheir closed ends. In at least one such embodiment, proximal end 3105 ofsecond handle portion 3104 can be positioned distally with respect toproximal end 3103 of first handle portion 3102 such that second handleportion 3104 can be moved proximally in order to position projections3111 within slots 3115. In various other circumstances, first handleportion 3102 can be positioned proximally with respect to second handleportion 3104 and slid distally in order to position projections 3111within slots 3115.

In various embodiments, referring to FIG. 183, second handle portion3104 can be rotated toward first handle portion 3102 such that anvil3130 can be moved into position relative to staple cartridge 3150 and/orstaple cartridge channel 3122. In certain embodiments, first handleportion 3102 can be rotated toward second handle portion 3104 and/or thefirst and second handle portions can be rotated toward each other. Inany event, projections 3111 and slots 3115, when engaged with oneanother, can comprise a pivot about which one or both of the first andsecond handle portions can be moved relative to each other. In variousembodiments, second handle portion 3104 can be moved relative to firsthandle portion 3102 such that anvil 3130 is moved into close oppositionto staple cartridge 3150. In certain embodiments, referring to FIG. 184,second handle portion 3104 can be moved relative to first handle portion3102 such that latch projections 3131 extending from second handleportion 3104 can be aligned with and/or inserted into recesses 3127within first handle portion 3102. In various embodiments, referringprimarily to FIGS. 180 and 181, first handle portion 3102 can furtherinclude latching mechanism 3180 rotatably mounted thereto which can beutilized to engage latch projections 3131 extending from second handleportion 3104 and secure the first and second handle portions together.Although not illustrated, other embodiments are envisioned in which alatching mechanism is rotatably mounted to the second handle portion andlatch projections can extend from the first handle portion. In anyevent, in at least one embodiment, latching mechanism 3180 can bemounted to first frame 3110 by one or more pivot pins 3182 which can beconfigured to define an axis about which latch 3180 can be rotated.

In certain embodiments, referring now to FIGS. 182 and 183, latchingmechanism 3180 can include latch frame 3184 and, in addition, latchcover 3186 assembled to latch frame 3184. In other various embodiments,the latch cover and the latch frame can comprise an integral unit or, incertain embodiments, the latching mechanism may not even include acover. In certain embodiments, latch frame 3184 can be channel-shapedand can include a pair of opposed, elongated side walls 3185 which arespaced apart by a distance sufficient to span first frame portion 3110.In at least one embodiment, latch cover 3186 can be made of plastic,lightweight materials, and/or any other suitable materials, for example,while latch frame 3184 can be made of stainless steel and/or any othersuitable material, for example. In certain embodiments, when latchingmechanism 3180 is closed, as illustrated in FIG. 185, latch cover 3186can be aligned with first handle cover 3108. Latch cover 3186 caninclude contoured portion 3187 which can be configured to assist asurgeon in manipulating surgical instrument 3100 wherein, in at leastone embodiment, contoured portion 3187 can be aligned with, or at leastsubstantially aligned with, protrusion 3109 extending from first handlecover 3108. Latching mechanism 3180 can further include one or morelatch arms 3188 extending therefrom which can be configured to engageone or more latch projections 3131 extending from second handle portion3104 and pull and/or secure projections 3131 within recesses 3127 asillustrated in FIG. 185. In at least one embodiment, at least one oflatch arms 3188 can be integrally-formed with latch frame 3184. Incertain embodiments, referring to FIG. 184, at least one of latch arms3188 can include a distal hook 3189 which can be configured to wraparound at least a portion of projections 3131 so as to encompass orsurround, or at least partially encompass or surround, projections 3131.In at least one embodiment, latch arms 3188 can act as an over-centerlatch to maintain latching mechanism 3180 in its latched, or closed,position.

In use, in various circumstances, one of the first handle portion 3102and the second handle portion 3104 can be positioned on a first side oftissue within a surgical site and the other handle portion can berotated into position on the opposite side of the tissue. In suchembodiments, staple cartridge 3150 can be positioned on one side of thetissue and anvil 3130 can be positioned on the other side of the tissue.Thereafter, as also outlined above, latching mechanism 3180 can beactuated such that it can be moved between an open position and a closedposition in order to latch second handle portion 3104 to first handleportion 3102 and apply a clamping force to the tissue positioned betweenstaple cartridge 3150 and anvil 3130. In certain circumstances, latchingmechanism 3180 can be moved between an open position (FIG. 183), apartially-closed, or intermediate, position (FIG. 184), and a closedposition (FIG. 185). In at least one such embodiment, referring to FIGS.183 and 184, latching mechanism 3180 can be moved between an openposition in which latch arms 3188 are not engaged with projections 3131and a partially-closed position in which latch arms 3188 are engagedwith projections 3131 such that, although anvil 3130 has been at leastpartially brought into opposition to staple cartridge 3150, a sufficientgap can remain between anvil 3130 and staple cartridge 3150 which canallow end-effector 3120 to be repositioned relative to the tissue, forexample. Once the anvil 3130 and staple cartridge 3150 have beensufficiently positioned relative to the tissue, latching mechanism 3180can be moved between its partially-closed position and a closedposition, as illustrated in FIG. 185.

In various embodiments, further to the above, a surgical staplinginstrument can further include a biasing member which can be configuredto bias the first handle portion of a stapling instrument away from asecond handle portion. In at least one embodiment, as described ingreater detail further below, a spring, and/or any suitably resilientmaterial, can be positioned intermediate the first and second handleportions such that the anvil and staple cartridge of the staplinginstrument can be biased away from each other. In certain embodiments,the spring can be configured to at least partially separate the firstand second handle portions such that a gap exists between the anvil andthe staple cartridge, wherein the gap can be sufficient to allow tissueto be positioned therebetween. In use, a surgeon can position such asurgical stapling instrument without having to separate and hold thefirst and second handle portions apart from each other. Such aninstrument may be especially useful when the stapling instrument is in apartially-closed configuration and the surgeon is manipulating theinstrument within a surgical site. After the surgeon is satisfied withthe positioning of the stapling instrument, the surgeon can compressand/or disengage the spring and place the stapling instrument in aclosed configuration.

In various circumstances, as outlined above, the distal end of firsthandle portion 3102 can be moved relative to the distal end of secondhandle portion 3104, especially when latching mechanism 3180 is notengaged with, or only partially engaged with, projections 3131 of secondhandle portion 3104. In such circumstances, projections 3111 and slots3115 at the proximal ends of the first and second handle portions can beconfigured to retain at least the proximal ends of the first and secondhandle portions together when the distal ends of the first and secondhandle portions are being moved relative to each other, for example.Stated another way, projections 3111 and slots 3115 can cooperate toprevent, or at least inhibit, first handle portion 3102 from becomingcompletely detached from second handle portion 3104. In certainembodiments, a first handle portion can include a first lock portion anda second handle portion can include a second lock portion, wherein thefirst and second lock portions can be configured to be engaged with oneanother and prevent the first handle portion from becoming completelydetached from the second handle portion. In at least one embodiment,projections 3111 can comprise the first lock portion and slots 3115 cancomprise the second lock portion. Previous stapling instruments lackedsuch lock portions and instead relied on a sole latching mechanism tokeep the first and second handle portions together. In circumstanceswhere the latching mechanisms of these previous stapling instrumentswere not fully engaged with both of the first and second handleportions, the first and second handle portions could become completelydetached from one another, thereby requiring a surgeon, for example, toreposition and reassemble the handle portions. In certain circumstances,a complete detachment of the first and second handle portions of theseprevious staples could expose at least a portion of a cutting member.

In various embodiments, as outlined above, latching mechanism 3180 canbe configured to be moved between an open position, a partially-closedposition, and a closed position. When latching mechanism 3180 is in itsopen position, as also outlined above, projections 3111 can be insertedinto and/or removed from slots 3115. When latching mechanism 3180 is inits partially-closed position, referring to FIG. 184, latch arms 3188can be configured to engage latch projections 3131 such that projections3111 cannot be removed from slots 3115. In at least one such embodiment,latch arms 3188 and latch projections 3131 can be configured to prevent,or at least inhibit, second handle portion 3104 from being moveddistally with respect to first handle portion 3102 and, as a result,prevent, or at least inhibit, projections 3111 from being disengagedfrom slots 3115. Correspondingly, latch arms 3188 and latch projections3131 can be configured to prevent first handle portion 3102 from beingmoved proximally with respect to second handle portion 3104. Similar tothe above, in various embodiments, latch arms 3188 and latch projections3131 can also be configured to prevent, or at least inhibit, projections3111 from being removed from slots 3115 when latching mechanism 3180 isin its closed position (FIG. 185). In certain embodiments, further tothe above, latch projections 3131 can extend from second handle portion3104 at a location which is intermediate its proximal and distal ends.In at least one such embodiment, projections 3111 and slots 3115 can beconfigured to hold the first and second handle portions together attheir proximal ends while latching mechanism 3180 can be utilized tohold the first and second handle portions together at an intermediatelocation. In any event, in certain embodiments, the first and secondhandle portions cannot be disengaged from one another unless latchingmechanism 3180 is moved into its fully open position. In at least onesuch embodiment, projections 3111 and slots 3115 cannot be disengagedfrom one another when latching mechanism 3180 is in a closed and/orpartially-closed position.

Once anvil 3130 and staple cartridge 3150 have been sufficientlypositioned, the tissue positioned intermediate anvil 3130 and staplecartridge 3150 can be stapled and/or incised. In various embodiments,referring to FIG. 181, surgical stapling instrument 3100 can furtherinclude pusher bar assembly 3200 which can be configured to advanceand/or retract staple sled assembly 3160 within staple cartridge 3150,for example. In at least one embodiment, pusher bar assembly 3200 caninclude pusher bar 3202 and firing actuator 3204, wherein firingactuator 3204 can be configured to move pusher bar 3202 and staple sledassembly 3160 distally to deploy staples from staple cartridge 3150 anddeform the staples against anvil 3130 as described above. In at leastone embodiment, referring to FIGS. 189 and 190, staple sled 3162 caninclude a groove, channel, or slot 3161 which can be configured toreceive, and can be operably connected to, a distal end 3201 (FIG. 181)of pusher bar 3202. In certain embodiments, staple sled assembly 3160can be operably engaged with pusher bar 3202 when staple cartridge 3150is inserted into staple cartridge channel 3122. In at least oneembodiment, distal end 201 and slot 3161 can include cooperatingfeatures which can allow distal end 3201 and slot 3161 to be assembledin a transverse direction but prevent, or at least inhibit, distal end3201 and slot 3161 from being disassembled from one another in aproximal direction and/or distal direction. In other embodiments, pusherbar 3202 can be advanced distally before contacting and engaging staplesled assembly 3160. In at least one such embodiment, the staple sledassembly 3160 can remain stationary until contacted by pusher bar 3202.In any event, as outlined above, actuator 3204 can be operably connectedto pusher bar 3202 such that a pushing and/or pulling force can beapplied to actuator 3204 and transmitted to pusher bar 3202. In certainembodiments, as described in greater detail below, actuator 3204 can bepivotably connected to a proximal end 3203 of pusher bar 3202 such thatactuator 3204 can be selectively rotated between at least first andsecond positions.

Further to the above, referring to FIGS. 179, 191, and 192, actuator3204 can be movable between a first position on a first side 3116 ofsurgical stapling instrument 3100 (FIG. 191), a second position on asecond side 3117 (FIG. 192), and an intermediate position (FIG. 179)located at the proximal ends 3103 and 3105 of the first and secondhandle portions 3102 and 3104. Once actuator 3204 has been rotated intoposition on one of the first and second sides 3116, 3117, actuator 3204can be advanced distally. In various circumstances, as a result, asurgeon may select whether to move actuator 3204 distally along firstside 3116 or second side 3117. Such circumstances may arise when it ismore likely that actuator 3204 may impinge on tissue surrounding thesurgical site, for example, when actuator 3204 is moved distally alongone side of the surgical instrument as compared to the other. In variousembodiments, referring to FIGS. 180 and 181, actuator 3204 can includearm 3206 extending therefrom where arm 3206 can be pivotably mounted toproximal end 3203 of pusher bar 3202. In certain embodiments, referringonce again to FIGS. 179, 191, and 192, surgical instrument 3100 caninclude a first slot (not illustrated) extending along first side 3116and a second slot 3118 extending along second side 3117, wherein thefirst and second slots can be configured to slidably receive at least aportion of actuator 3204. In at least one embodiment, the sidewalls ofthe first and second slots can confine, or at least assist in confining,the movement of actuator 3204 such that it can be moved along apredetermined path. Referring to FIG. 192, second slot 3118, forexample, can be defined between first handle portion 3102 and secondhandle portion 3104 such that, when actuator 204 is moved distally alongsecond side 3117, arm 3206 of actuator 3204 can be slid intermediate thefirst and second handle portions. Similar to the above, the first slotcan also be defined intermediate the first and second handle portions.In various embodiments, referring again to FIGS. 191 and 192, surgicalinstrument 3100 can further include intermediate slot 3119 which canalso be configured to allow arm 3206, and/or any other suitable portionof actuator 3204, to slide therein. In at least one such embodiment,intermediate slot 3119 can connect the first and second slots such that,when actuator 3204 is positioned in its intermediate position, actuator3204 can be moved into either one of its first and second positions. Incertain embodiments, the first slot, second slot 3117, and intermediateslot 3119 can be parallel, or at least substantially parallel, to oneanother and/or lie in the same plane, although other embodiments areenvisioned in which one or more of the slots is not parallel to theothers and/or lies in a different plane. Furthermore, although the firstand second sides of the illustrated embodiment are located on oppositesides of surgical instrument 3100, other embodiments are envisionedwhere the first and second slots, for example, are located on adjacentsides and/or sides which are not directly opposite to each other.Furthermore, other embodiments are envisioned in which the sides of astapling instrument are not readily discernable, such as instrumentshaving round and/or arcuate portions.

In various embodiments, further to the above, surgical staplinginstrument 3100 can further include a locking mechanism which canprevent, or at least inhibit, actuator 3204 and, correspondingly, staplesled assembly 3160, from being advanced prematurely. In at least oneembodiment, the locking mechanism can be configured to prevent, or atleast inhibit, actuator 3204 from being advanced distally prior tolatching mechanism 3180 being moved into a closed, or an at leastpartially-closed, position. In certain embodiments, generally referringto FIG. 183, surgical stapling instrument 3100 can further includinglocking mechanism 3220 which can be engaged with actuator 3204 and canremain engaged with actuator 3204 while latching mechanism 3180 is in afully open position (FIG. 183) and/or an at least substantially-openposition. In various embodiments, locking mechanism 3220 can includelock 3222 which can be biased into engagement with actuator 3204 by abiasing force applied thereto by lock spring 3224, for example. In atleast one such embodiment, actuator 3204 can include one or moregrooves, channels, or slots (not illustrated) which can be configured toreceive at least a portion of lock 3222. In use, locking mechanism 3220can hold actuator 3204 in position until latching mechanism 3180 ismoved into its fully closed position (FIG. 185) and/or an at leastsubstantially closed position. In such circumstances, in at least oneembodiment, latching mechanism 3180 can be configured to engage lockingmechanism 3220 and disengage lock 3222 from actuator 3204. In at leastone such embodiment, referring to FIGS. 183-185, latching mechanism 3180can further include cam 3183 which can be configured to engage camsurface 3223 on lock 3222 when latching mechanism 3180 is moved into itsclosed position and, as a result, slide, and/or otherwise move, lock3222 away from actuator 3204. In various embodiments, cam 3183 cancomprise a wall, rib, and/or ridge extending from latch cover 3186and/or latch frame 3184. In any event, once lock 3222 has beensufficiently disengaged from actuator 3204, in at least one embodiment,actuator 3204 can be moved from its intermediate position, illustratedin FIG. 179, into one of its first and second positions, as illustratedin FIGS. 191 and 192.

As described above, locking mechanism 3220 can be configured to prevent,or at least inhibit, drive bar 3202 from being advanced distally priorto latching mechanism 3180 being moved into a predetermined position,such as, for example, a closed position and/or partially-closedposition. Advantageously, locking mechanism 3220 may also prevent, or atleast inhibit, staple sled assembly 3160 from being advanced prior tothe first handle portion 3102 and the second handle portion 3104 beingassembled together. In effect, locking mechanism 3220 can prevent tissuepositioned intermediate anvil 3130 and staple cartridge 3150 from beingcut and/or stapled prior to anvil 3130 and staple cartridge 3150 beingproperly positioned relative to the tissue. Also, in effect, lockingmechanism 3220 can prevent staples from being deployed into the tissueprior to an appropriate clamping force being applied to the tissue. Inany event, when latching mechanism 3180 is returned to its fully openposition, and/or a partially-open position, cam 3183 can be moved awayfrom lock 3222 such that lock spring 3124 can bias lock 3222 intoengagement with actuator 3204 once again. In various other embodiments,referring to FIGS. 193 and 194, locking mechanism 3220′ can include alock 3222′ comprising a cam surface 3223′ and, in addition, a stop 3226′which can limit the relative movement of lock 3222′. In at least oneembodiment, cam 3183, for example, can be configured to contact camsurface 3223′ and, owing to the contoured, beveled, and/or angledsurface of cam surface 3223′, cam 3183 can be configured to drive lock3222′ distally as illustrated in FIG. 194. Lock 3222′ can be drivendistally such that pin 3228′, which extends from lock 3222′, can bemoved between a first position (FIG. 193) in which it is positionedwithin aperture 3229′ in actuator 3204′ and a second position (FIG. 194)in which pin 3228′ has been sufficiently removed from aperture 3229′. Invarious embodiments, stop 3226′ can be configured such that, as lock3222′ is driven distally, stop 3226′ can come into contact with cam 3183once lock 3222′ has been sufficiently displaced. In such embodiments,stop 3226′ can be configured to control the second, or displaced,position of lock 3222′ Similar to the above, as actuator 3180 is movedout of its closed position and cam 3183 is disengaged from lockingmechanism 3220′, lock spring 3224′ can move lock 3222′ into engagementwith actuator 3204′ once again.

In various embodiments, as described above, a firing actuator can beutilized to move a pusher bar, staple sled, and/or cutting memberbetween first and second positions. As also described above, pusher barassembly 3200, for example, can be utilized to move a staple sledassembly, such as staple sled assembly 3160, for example, between aproximal position (FIG. 188) and a distal position. In certainembodiments, a staple cartridge, such as staple cartridge 3150, forexample, can include a staple sled assembly 3160 contained therein,wherein staple sled assembly 3160 can be positioned in a distalposition, as illustrated in FIG. 188, when the staple cartridge isassembled to or inserted into staple cartridge channel 3122. In at leastone such embodiment, referring to FIGS. 186-188, staple cartridge 3150can include further housing 3170 which can be configured to cover atleast a portion of cutting member 3164 when staple sled assembly 3160 isin its distal position, for example. In various embodiments, housing3170 can be configured to protect a surgeon, for example, when handlingthe staple cartridge, when inserting the staple cartridge into thesurgical stapler, and/or assembling two or more portions of the surgicalstapler together, for example. In at least one such embodiment, at leastan upper portion of cutting edge 3165 can extend above deck, or topsurface, 3158 of staple cartridge 3150 and, absent a protective housing,such as housing 3170, for example, the upper portion of cutting edge3165 may be exposed.

In various embodiments, as described above, cutting member 3165 can beat least partially positioned within slot, or channel, 3156 and, asillustrated in FIG. 188, at least the upper, or top, portion of cuttingmember 3164 can extend above deck 3158. In at least one embodiment,referring to FIGS. 186-188, housing 3170 can include a first wall, orportion, 3172 extending from a first portion 3157 of staple cartridgebody 3152, a second wall, or portion, 3174 extending from a secondportion 3159 of staple cartridge body 3152, and a top wall, or portion,3176 extending between first wall 3172 and second wall 3174. In certainembodiments, a housing may comprise only one support wall, or supportportion, extending from a staple cartridge body and, in addition, a topwall, or top portion, extending therefrom. In other embodiments, ahousing may comprise one or more side walls, or portions, and no topwall. In at least one such embodiment, the side walls of the housing canbe configured such that they extend above the top of the cutting member,or at least extend above a cutting edge of the cutting member, forexample. In any event, as illustrated in FIG. 188, at least a portion ofcutting member 3164 can be positioned underneath top wall 3176 and/orbetween side walls 3172 and 3174 when staple sled assembly 3160 is inits proximal position. In certain embodiments, cutting member 3164 canbe entirely positioned underneath top wall 3176, and/or entirelypositioned within housing 3170. In at least one embodiment, cuttingmember 3164 can be positioned underneath top wall 3176 such that cuttingsurface 3165 does not extend beyond the distal edge 3175 and/or theproximal edge 3177 of top wall 3176. In at least one embodiment, housing3170 can include a rear wall 3178 which can be configured to limit theproximal movement of cutting member 3164 and/or any other portion ofstaple sled assembly 3160. In various embodiments, at least a portion ofhousing 3170, for example, can be integrally-formed with staplecartridge body 3152. In at least one such embodiment, first wall 3172,second wall 3174, top wall 3176, and/or rear wall 3178 can be formedwhen staple cartridge body 3152 is injection molded, for example. Incertain embodiments, at least a portion of housing 3170 can be assembledto staple cartridge body 3152 via a snap-fit arrangement, press-fitarrangement, and/or any other suitable manner.

In various embodiments, further to the above, cutting member 3164 can bedefined by a planar, or an at least substantially planar, body having aknife edge extending along at least one side of the cutting member body.In at least one such embodiment, first wall 3172 and/or second wall 3174can be configured and arranged such that they can include planar, or atleast substantially planar, interior surfaces 3173 which are parallel,or at least substantially parallel, to the side surfaces of cuttingmember 3164. In certain embodiments, cutting member 3164 can be closelyreceived between the interior surfaces 3173 of walls 3172 and 3174. Inat least one such embodiment, the distance between walls 3172 and 3174may be the same as, or at least substantially the same as, the width ofslot 3156. In any event, a housing can be configured such that at leasta portion of the housing extends over at least a portion of slot 3156,for example. In certain embodiments, housing 3170 can completely encloseor surround a cutting member 3164 and/or cutting surface 3165. In atleast one embodiment, although not illustrated, a housing can include abreak-away and/or incisable portion which can be at least partiallydetached, separated, and/or otherwise deformed in order to permit acutting member to exit the housing. In at least one such embodiment, thetissue cutting surface can be configured to contact the housing to breakand/or incise a housing wall, for example. In various embodiments, thehousing wall can include a thin portion, a reduced-thickness portion,score mark, and/or any other configuration to facilitate the deformationand/or incision of the housing wall. In certain embodiments, a cuttingmember can include one or more additional cutting surfaces and/oranvils, for example, which can be configured to deform and/or incise thehousing. In at least one embodiment, the housing can include a movableand/or flexible portion, such as a hinged member and/or flexible flap,for example, which can be configured to sufficiently move and/or flex toallow the cutting member to pass thereby. In any event, embodiments areenvisioned in which the cutting member can have any suitableconfiguration for incising tissue and the protective housing can haveany suitable configuration for at least partially enclosing orsurrounding the cutting member. Furthermore, although a cutting membercan comprise a sharpened edge as described above, other suitable cuttingmembers are envisioned, such as those supplied with an electricalcurrent sufficient to dissect tissue, for example.

As described above, housing 3170 can be configured to at least partiallycover, enclose, and/or surround a cutting member when it is in itsproximal position. In various embodiments, the cutting member can beadvanced distally to incise tissue, for example, and then retractedproximally in order to position the cutting member within housing 3170once again. In such embodiments, the cutting member can be at leastpartially covered by housing 3170 when the staple cartridge is assembledto and removed from a surgical stapling instrument. In certainembodiments, a new, or unspent, staple cartridge can be inserted intothe staple cartridge channel to replace the at least partially spentstaple cartridge. In at least one such embodiment, the new staplecartridge can include a new cutting member and/or staple sled assemblypositioned therein, although embodiments are envisioned in which thepreviously-used cutting member and/or staple sled assembly can besufficiently withdrawn from the spent staple cartridge and advanced intothe new staple cartridge in order to be reused once again. Inembodiments where a new cutting member and/or staple sled assembly isprovided with each new staple cartridge, a sharp cutting edge, forexample, can be utilized with each staple cartridge.

In various embodiments, although not illustrated, a staple cartridge caninclude two or more housings configured to at least partially cover acutting member when it is in two or more positions. In at least oneembodiment, a staple cartridge can include a proximal housing configuredto at least partially cover the cutting member when it is in a proximalposition, for example, and, in addition, a distal housing configured toat least partially cover the cutting member when it is in a distalposition, for example. In at least one such embodiment, the cuttingmember can be positioned within the proximal housing when the staplecartridge is assembled to a surgical stapling instrument and, in certainembodiments, the cutting member can be advanced into the distal housingafter it has transected tissue positioned within the end-effector, forexample. In such embodiments, as a result, the cutting member can be atleast partially positioned within the distal housing when the staplecartridge is removed from the surgical stapler. Such embodiments may beparticularly useful when a vessel, for example, is positionedintermediate the proximal housing and the distal housing of the staplecartridge. In various embodiments, although not illustrated, a cuttingmember can be moved proximally from a distal position to a proximalposition, and/or any other suitable position.

In various embodiments, further to the above, anvil 3130 can include oneor more apertures, slots, or recesses 3179 (FIG. 195) which can beconfigured to receive at least a portion of housing 3170 when anvil 3130is brought into close opposition to staple cartridge 3150, for example.In at least one embodiment, sufficient clearance can be present betweenhousing 3170 and recess 3179 such that anvil 3130 and staple cartridge3150 can be moved relative to each other without interference, or atleast substantial interference, therebetween. In embodiments having morethan one cutting member housing as outlined above, an opposing anvil canhave more than one corresponding aperture for receiving the housings. Invarious embodiments, an anvil can include a movable cutting member andat least one housing for at least partially covering, enclosing, and/orsurrounding the cutting member. In certain embodiments, although notillustrated, both an anvil and a staple cartridge can comprise at leastone movable cutting member and/or at least one housing configured to atleast partially cover, surround, or enclose the cutting members whenthey are in a proximal position, for example.

As outlined above, pusher bar assembly 3200 can be advanced distally inorder to move staple sled assembly 3160 within staple cartridge assembly3150. In various embodiments, as also outlined above, the wedge-like camsurfaces 3167 of staple sled 3162 can be moved into engagement with thesloped surfaces 3169 on staple drivers 3168 to sequentially, and/orsimultaneously, drive staples from staple cartridge 3150 against anvil3130 and form the staples into any suitable configuration, such asB-shaped configurations, for example. In at least one such embodiment,referring to FIG. 195, anvil 3130 can include one or more staple formingsurfaces, such as staple pockets 3132, for example, which can beconfigured to deform the staples. In certain embodiments, anvil 3130 canfurther include a slot, channel, or groove 3133 which can be configuredto slidably receive at least a portion of staple sled 3162, cuttingmember 3164, and/or pusher bar 3202, for example. In at least oneembodiment, although not illustrated, an anvil can include an anvilplate which can be securely and/or immovably positioned within an anvilchannel defined within the anvil. In various other embodiments, asillustrated in FIGS. 196 and 197 and described in greater detail below,anvil 3130 can include an anvil plate 3134 movably positioned withinanvil channel 3136. In certain embodiments, anvil channel 3136 caninclude opposite side walls 3137 and, in addition, a base 3138 extendingbetween side walls 1337. In at least one embodiment, anvil 3130 canfurther include a distal nose portion 3139, for example, assembledthereto wherein nose portion 3139 can be configured to be press-fitand/or snap-fit into anvil channel 3136, for example, such that noseportion 3139 can be securely retained therein. In certain embodiments,nose portion 3139 can be comprised of a soft and/or pliable material,such as rubber, for example, and can comprise any suitable shape whichcan facilitate the insertion of anvil 3130 into a surgical site, forexample. In some embodiments, referring to FIG. 206, a nose portion,such as nose portion 3139′ can be retained to an anvil by one or morefasteners 3139 a′. Similarly, referring to FIG. 179, a staple cartridgechannel and/or staple cartridge, such as staple cartridge 3150, forexample, can include a nose portion, such as nose portion 3153, forexample, which can facilitate the insertion of staple cartridge 3150into a surgical site, for example.

As indicated above, staples can be deployed from a staple cartridge anddeformed against an anvil. In various circumstances, the distancebetween the staple forming surfaces on anvil 3130 and staple sled 3162can determine the amount in which the staples are deformed. For example,if the distance between anvil pockets 3132 on anvil 3130 and topsurfaces 3135 on staple sled 3162 (FIGS. 188-190) is relatively large,the staples will be deformed a lesser amount as compared to when thedistance between anvil pockets 3132 and sled surfaces 3135 is relativelysmall. Correspondingly, if the distance between anvil pockets 3132 andsled surfaces 3135 is relatively small, the staples will be deformed agreater amount as compared to when the distance between anvil pockets3132 and sled surfaces 3135 is relatively large. Often, the distancebetween anvil pockets 3132 and sled surfaces 3135 is referred to as theforming height of the staples. Sometimes the forming height of thestaples can be measured between the top surface, or deck, of the staplecartridge and the staple forming surfaces on the anvil. For the purposeof this application, however, any reference to a staple forming height,or the like, can include one or both manners of measurement, whereappropriate, and/or any other suitable manner of measurement. In anyevent, as described in greater detail below, a surgical staplinginstrument, such as stapling instrument 3100, for example, can includemeans for adjusting the staple forming height.

In various embodiments, further to the above, an anvil can include oneor more forming surfaces which can be moved toward and/or away from astaple cartridge in order to set the forming height of the staples. Inat least one embodiment, referring to FIGS. 195-201, anvil 3130 caninclude anvil plate 3134 which can be movably and/or slidably positionedwithin anvil channel 3136. In certain embodiments, anvil 3130 canfurther include one or more retention, or guide, pins 3140, whereinanvil plate 3134 can include one or more retention, or guide, slots 3141configured to slidably receive at least a portion of pins 3140. In atleast one such embodiment, pins 3140 and/or slots 3141 can be configuredto define a predetermined path along which anvil plate 3134 can bemoved. Referring to FIG. 196, pins 3140 and slots 3141 can be structuredand arranged such that anvil plate 3134 can be moved along a linear, orat least substantially linear, path, wherein the linear path can be atleast partially defined by axes 3142 and 3143, for example. Otherembodiments are envisioned in which an anvil plate can be moved along anon-linear path, such as a curved and/or curvi-linear path, for example.In certain embodiments, at least a portion of pins 3140 can be retainedwithin apertures 3144 in side walls 3137 wherein, in at least oneembodiment, pins 3140 can be press-fit within apertures 3144. In anyevent, as described herein, pins 3140 can guide anvil plate 3134 as itis moved toward and/or away from staple cartridge 3150, for example.

In various embodiments, further to the above, a surgical staplinginstrument, such as stapling instrument 3100, for example, can includeone or more adjustment members configured to position a portion of ananvil, such as anvil plate 3134, for example, relative to other portionsof an anvil assembly and/or an opposing staple cartridge. In certainembodiments, referring to FIGS. 196 and 197, stapling instrument 3100can include anvil plate adjustment member 3230 which can be configuredto limit the range of motion of anvil plate 3134. In at least one suchembodiment, referring to FIGS. 198 and 199, adjusting member 3230 can bepositioned intermediate anvil plate 3134 in a first position in whichfirst surface, or step, 3231 of adjusting member 3230 is positionedintermediate base 3138 of anvil channel 3136 and first positioningsurface 3145 on anvil plate 3134. In such a first position, first step3231 can define the amount of relative movement possible, or permitted,between anvil plate 3134 and anvil channel 3136. For example, when anvil3130 is clamped against tissue as described above, anvil plate 3134 cancontact the tissue and slide upwardly toward base 3138 until firstpositioning surface 3145 contacts first step 3231. Once surface 3145 andstep 3231 are in contact, adjusting member 3230 can prevent, or at leastinhibit, anvil plate 3134 from moving further toward base 3138. In atleast one such embodiment, as a result, adjusting member 3230 can act asa stop such that the distance between base 3138 and tissue-contactingsurface 3148 on anvil plate 3134 can be defined by a first distance3234. While base 3138 is used as a reference datum in the presentexample, other portions of anvil 3130 and/or an opposing staplecartridge, for example, could be used as reference datums. Whenadjusting member 3230 is in its first position, as described above,second surface, or step, 3232 of adjusting member 3230 can be positionedintermediate base 3138 and second positioning surface 3146 on anvilplate 3134, and, in addition, third surface, or step, 3233 can bepositioned intermediate base 3138 and third positioning surface 3147.Referring to FIG. 198, adjustment member 3230 can include two or moresets of steps, 3231, 3232, and/or 3233 and anvil plate 3134 can includetwo or more sets of positioning surfaces 3145, 3146, and/or 3147. Whilefirst step 3231 and first positioning surface 3145 are described aboveas being configured to control the position of anvil plate 3134, thesecond and third steps (3232, 3233) of adjustment member 3230 and thesecond and third positioning surfaces (3146, 3147) of anvil plate 3134,respectively, can also be configured to control the position of anvilplate 3134. For the sake of brevity, though, the present example will bedescribed in reference to the first surface, or step 3231, as being thesurface which controls the position of anvil plate 3134, although thereader will understand that the steps 3232 and 3233 can control theposition of anvil plate 3134 as well.

In certain embodiments, the first position of adjustment member 3230 canprovide for a relatively small, or short, staple forming height. Inother embodiments, although not illustrated, the first position of anadjustment member can provide for an intermediate, a relatively large,and/or any other suitable staple forming height. In the event that theforming height associated with the first position of the adjustmentmember is suitable, a surgeon can proceed to use the surgical staplinginstrument to staple and/or incise tissue as described above. In theevent, however, that the staple forming height is unsuitable, a surgeon,or other clinician, can move adjustment member 3230 such that adjustmentmember 3230 can permit anvil plate 3134 to slide upwardly a differentdistance when anvil plate 3134 contacts tissue positioned intermediateanvil 3130 and staple cartridge 3150. In at least one such circumstance,the distance in which anvil plate 3134 is permitted to slide upwardlycan be larger, thereby providing a larger forming height for thestaples. Correspondingly, in other circumstances, the adjustment membercan be moved such that anvil plate 3134 can slide upwardly a shorterdistance when anvil plate 3134 contacts the tissue, for example, therebyproviding a shorter staple forming height. While the term “upward”, andthe like, can mean vertically upward, the term is not so limited;rather, “upward” can mean any direction which is toward the base of theanvil and/or away from a staple cartridge, for example. In any event,adjustment member 3230 can be moved between its first position,illustrated in FIG. 199, and a second position, illustrated in FIG. 200,in order to increase the staple forming height. As indicated by arrow“P” in FIG. 200, adjustment member 3230 can be slid proximally in orderto move adjustment member 3230 between its first and second positions,although embodiments are envisioned where an adjustment member can beslid distally and/or any other suitable direction in order to adjustadjustment member 3230. Once adjustment member 3230 has been moved intoits second position, referring to FIG. 200, first surface, or step, 3231can be positioned intermediate base 3138 and second positioning surface3146 of anvil plate 3134. In such a second position, first step 3231 canonce again define the amount of relative movement permitted betweenanvil plate 3134 and anvil channel 3136. In at least one embodiment,similar to the above, adjusting member 3230 can act as a stop such thatthe distance between base 3138 and tissue-contacting surface 3148 onanvil plate 3134 can be defined by a second distance 3235.

Further to the above, adjustment member 3230 can be moved between itssecond position, illustrated in FIG. 200, and a third position,illustrated in FIG. 201, in order to once again increase the stapleforming height. As indicated by arrow “P” in FIG. 201, adjustment member3230 can be slid proximally in order to move adjustment member 3230between its second and third positions. Once adjustment member 3230 hasbeen moved into its third position, referring to FIG. 201, firstsurface, or step, 3231 can be positioned intermediate base 3138 andthird positioning surface 3147. In such a third position, first step3231 can once again define the amount of relative movement between anvilplate 3134 and anvil channel 3136. In at least one embodiment, similarto the above, adjusting member 3230 can act as a stop such that thedistance between base 3138 and tissue-contacting surface 3148 on anvilplate 3134 can be defined by a third distance 3236. While adjustmentmember 3230 can be selectively moved between three positions asdescribed above to provide three different staple forming heights, otherembodiments are envisioned which comprise an adjustment member which canbe moved between more than three positions to provide more than threedifferent staple forming heights. For example, an adjustment member canbe movable between four positions in order to provide four stapleforming heights. Further embodiments are envisioned which comprise anadjustment member which can be moved between two positions to providetwo staple forming heights. Furthermore, while surfaces, or steps, 3231,3232, and 3233 of adjustment member 3230 are arranged in a descendingorder, other arrangements are envisioned in which the surfaces, orsteps, are arranged in an ascending order. Other arrangements areenvisioned in which the surfaces, or steps, are not necessarily arrangedin either an ascending or a descending order. Similarly, positioningsurfaces 3145, 3146, and 3147 of anvil plate 3134 can be arranged in anascending order, a descending order (FIG. 198), and/or any othersuitable order. Furthermore, while adjustment member 3230 can be slidalong an axis, other embodiments are envisioned where an adjustmentmember can be moved along any suitable path such as curved and/orcurvi-linear paths, for example.

As described above, referring to FIG. 199, adjustment member 3230 cancomprise three surfaces, or steps, 3231, 3232, and 3233 while anvilplate 3134 can comprise three corresponding adjustment surfaces 3145,3146, and 3147. When adjustment member 3230 is in its first position,for example, first surface 3231 can be positioned such that it abuts oris adjacent to first adjustment surface 3145, second surface 3232 can bepositioned such that it abuts or is adjacent to second adjustmentsurface 3146, and third surface 3233 can be positioned such that itabuts or is adjacent to third adjustment surface 3147. As adjustmentmember 3230 is slid relative to anvil plate 3134, as described above andreferring to FIGS. 200 and 201, surfaces 3231, 3232, and 3233 ofadjustment member 3230 can be sequentially indexed relative to surfaces3145, 3146, and 3147 of anvil plate 3134. In at least one suchembodiment, an adjustment member can have the same number of steps asthe number of positioning surfaces on an anvil plate. Other embodimentsare envisioned where an adjustment member has more steps thanpositioning surfaces on the anvil plate. In at least one suchembodiment, an anvil plate can include one positioning surface whereinthe steps of an adjustment member can be selectively utilized to limitthe upward movement of the anvil plate, for example. In variousembodiments, referring generally to adjustment member 3230 and anvilplate 3134, an anvil plate may include one positioning surface, such aspositioning surface 3145, for example, where steps 3231, 3232, and 3233of adjustment member 3230, for example, can be selectively positionedintermediate base 3138 and positioning surface 3145. In suchembodiments, first step 3231 can have a first thickness or height whichcan stop, or limit, the upward movement of anvil plate 3134 so as todefine a first staple forming height, second step 3232 can have a secondthickness or height which can stop, or limit, the upward movement ofanvil plate 3134 so as to define a second staple forming height, and, inaddition, third step 3233 can have a third thickness or height which canstop, or limit, the upward movement of anvil plate 3134 so as to definea third staple forming height. In at least one embodiment, the thicknessor height of steps 3231, 3232, and/or 3233 can be measured between aback surface 3237 of adjustment member 3230 and a surface on the steps(3231, 3232, 3233) which will contact anvil plate 3134. In variousembodiments, the difference in height, or thickness, between first step3231 and second step 3232 can be the same, or at least substantially thesame, as the difference in height, or thickness, between second step3232 and third step 3233. In at least one such embodiment, as a result,the step heights can increase at a linear rate, or an at leastsubstantially linear rate. In alternative embodiments, the difference inheight, or thickness, between the first and second steps can bedifferent than the difference in height, or thickness, between thesecond and the third steps. In at least one such embodiment, the first,second, and third steps may not increase or decrease in height, orthickness, at a linear rate; rather, although not illustrated, the stepsmay increase or decrease in height, or thickness, in a non-linear and/orgeometric rate.

As described above, an adjustment member, such as adjustment member3230, for example, can be movable between two or more positions. Invarious embodiments, a surgical stapling instrument can include anactuator configured to move the adjustment member. In at least oneembodiment, referring to FIGS. 195-198, surgical stapling instrument3100 can include actuator 3250 which can be operably attached toadjustment member 3230 such that a force can be applied to actuator 3250and transmitted to adjustment member 3230. In certain embodiments,actuator 3250 can include grasping portions, or handles, 3252 which canbe configured to be grasped by a surgeon, for example, in order toadvance or retract adjustment member 3230 within anvil 3130 as describedabove. In certain embodiments, grasping portions 3252 can extend fromactuator body 3251, wherein actuator body 3251 can include one or moreapertures, slots, or cavities 3253 which can be configured to receive atleast a portion of adjustment member 3230. In at least one suchembodiment, referring to FIG. 197, adjustment member 3230 can includelock 3254 extending therefrom, wherein at least a portion of lock 3254can be received within aperture 3253 so as to retain actuator body 3251to adjustment member 3230. In various embodiments, lock 3254 can includeone or more resilient, or flexible, legs 3255 which can be deflectedwhen they are inserted into aperture 3253 but resiliently return, or atleast partially return, to their unflexed position after feet 3256 oflegs 3255 are sufficiently pushed through aperture 3253. In at least onesuch embodiment, feet 3256 can prevent, or at least inhibit, actuatorbody 3251 from being detached from adjustment member 3230.

In various embodiments, further to the above, surgical staplinginstrument 3100 can further include a detent mechanism which can beconfigured to hold, or releasably hold, actuator 3250 and/or adjustmentmember 3230 in position. In at least one embodiment, referring to FIG.197, detent member 3260 can be attached to actuator 3250 wherein, in atleast some embodiments, actuator body 3251 can include one or morechannels, grooves, or recesses 3257 which can be configured to receiveand/or retain a detent body 3261 of detent member 3260 therein. In atleast one embodiment, detent body 3261 can include one or more apertures3263, and/or any other suitable channels, slots, or grooves, which canbe configured to receive one or more fasteners for securing detent body3261 to actuator 3251, for example. Detent member 3260 can furtherinclude detent legs 3262 which can be configured to engage one or morerecesses, apertures, or grooves 3101 (FIGS. 180-185) in first frameportion 3110, for example. More particularly, referring to FIGS. 180 and181, each side flange 3128 can include one or more recesses 3101 (3101a, 3101 b, and 3101 c) defined therein wherein detent legs 3262 can bebiased into engagement with the top surfaces of side flanges 3128 suchthat detent legs 3262 can be slid into, and slid out of, recesses 3101.In the illustrated embodiment, each side flange can include threerecesses 3101 which can be configured to removably hold actuator 3250 ina first, distal position, a second, intermediate position, and a third,proximal position, wherein the first, second, and third positions ofactuator 3250 can respectively correspond with the first, second, andthird positions of adjustment member 3230 described above. For example,when actuator 3250 is in its first, distal position, detent legs 3262 ofdetent member 3260 can be positioned within recess 3101 a so as toremovably retain actuator 3250 and adjustment member 3230 in their firstpositions. Upon the application of a sufficient force, actuator 3250 canbe moved proximally into its second position such that detent legs 3162are positioned within recess 3101 b and actuator 3250 and adjustmentmember 3230 are retained in their second positions. Similarly, upon theapplication of a sufficient force, actuator 3250 can be moved proximallyinto its third position such that detent legs 3162 are positioned withinrecess 3101 c and actuator 3250 and adjustment member 3230 are retainedin their third positions. In various embodiments, detent legs 3162 canbe configured such that actuator 3250 can be returned to its firstand/or second positions.

As described above, adjustment member 3230 can be moved along apre-determined path between two or more positions by actuator 3250. Invarious embodiments, surgical stapling instrument 3100, for example, caninclude one or more guides for controlling or limiting the movement ofadjustment member 3230 and/or actuator 3250. In some embodiments,adjustment member 3230 can be closely received between side walls 3137of anvil 3130 such that side walls 3137 can guide adjustment member3230. In at least one such embodiment, side walls 3137 can be configuredto control or limit the lateral or side-to-side movement of adjustmentmember 3230. In various embodiments, detent legs 3162 of detent member3160 can comprise resilient members which can be configured to apply anupward biasing or pulling force on adjustment member 3230 so as toposition adjustment member 3230 against, or at least adjacent to, base3138 and intermediate side walls 3137. In certain embodiments, referringto FIG. 197, base 3138 of anvil 3130 can further include guide slot 3149which can be configured to receive at least a portion of adjustmentmember 3230 and/or actuator 3250 therein such that guide slot 3149 canlimit the movement of adjustment member 3230 and actuator 3250. In atleast one such embodiment, lock 3254 of adjustment member 3230 can beconfigured to extend through guide slot 3149 such that, when lock 3254is inserted into aperture 3253 of actuator 3250 as described above, base3138 of anvil 3130 can be captured intermediate adjustment member 3230and actuator 3250. In certain embodiments, guide slot 3149 can beconfigured to limit the movement of lock 3254 such that adjustmentmember 3230 can be prevented, or at least inhibited, from being moveddistally when adjustment member 3230 is in its first, or distal-most,position and/or, similarly, prevented, or at least inhibited, from beingmoved proximally when adjustment member 3230 is in its third, orproximal-most, position.

In various embodiments, further to the above, a detent member, similarto detent member 3260, for example, can be utilized to bias first handleportion 3102 and second handle portion 3104 away from one another. In atleast one embodiment, referring to FIG. 215, surgical staplinginstrument 3100′ can include a detent member 3260′ configured toposition first handle portion 3102 and second handle portion 3104 suchthat a gap exists between anvil 3130 and staple cartridge 3150. Such afeature, as outlined above, can allow a surgeon to easily manipulate thesurgical instrument without having to hold the first and second handleportions apart from one another. In certain embodiments, detent member3260′ can be sufficiently mounted to second handle portion 3104 suchthat detent legs 3262′ extending from detent member 3260′ can contactflanges 3128 and, when compressed, apply a biasing force to the firstand second handle portions. As seen in FIG. 215, legs 3262′ can contactsurfaces 3101 d on flanges 3128. In order to compress detent legs 3262′,latch mechanism 3180 can be moved into a partially-closed position suchthat latch arms 3188 can engage, and at least partially surround, latchprojections 3131. In this configuration, a surgeon can manipulate theinstrument and, when satisfied with its position, move latch mechanism3180 into a closed position and further compress detent legs 3262′Similar to the above, detent member 3260′ can be affixed, or otherwiseoperably engaged with, actuator 3250 such that, when actuator 3250 ismoved between its first, second, and third positions as described above,legs 3262′ can engage recesses 3101 a, 3101 b, and 3101 c, respectively.In at least one such embodiment, as a result, actuator 3250 can have apre-staged position in which actuator 3250 is positioned distally withrespect to its first position and, in addition, surfaces 3101 d cancomprise pre-stage surfaces against which legs 3262′ can be positionedwhen actuator 3250 is in its pre-staged position.

As outlined above, an adjustment member can be slid, or translated,between first and second positions so as to adjust the forming height ofstaples deployed by a surgical stapling instrument. In variousembodiments, although not illustrated, an adjustment member can beconfigured to positively displace an anvil plate toward and/or away froman opposing staple cartridge, for example. In at least one suchembodiment, a surgical stapling instrument can include one or morebiasing members, such as springs, for example, configured to positionthe anvil plate against the adjustment member such that, when theadjustment member is moved between its first and second positions, theadjustment member can displace the anvil plate between first and secondpositions in order to set first and second staple forming heights. Invarious embodiments, as a result of the above, an adjustment member canbe configured to cam a portion of an anvil into position. In at leastone such embodiment, an adjustment member can be slid along an axis inorder to positively displace an anvil plate. In other embodiments, arotatable adjustment member can be configured to positively displace ananvil plate toward and/or away from a staple cartridge, for example.

Further to the above, as described in greater detail below, anadjustment member can be rotated to adjust the staple forming height.Referring to FIGS. 202-214, surgical instrument 3100′ can include,similar to the above, a first handle portion 3102′, a second handleportion 3104′, and a latching mechanism 3180′ which can be utilized toclamp tissue intermediate anvil 3130′ and staple cartridge 3150′.Referring to FIG. 203, also similar to the above, latching mechanism3180′ can be pivotably coupled to first portion 3102′ by one or morepivot pins 3182′, wherein latching mechanism 3180′ can include one ormore latch arms 3188′ which can be configured to engage second portion3104′ and latch the first and second handle portions together. Alsosimilar to the above, referring to FIGS. 203 and 205, surgicalinstrument 3100′ can further include pusher bar assembly 3200′ which canbe configured to advance a cutting member and/or staple sled withinend-effector 3120′. In at least one such embodiment, pusher bar assembly3200′ can include a proximal end 3203′ and an actuator 3204′, whereinactuator 3204′ can be rotatably mounted to proximal end 3203′ andselectively positioned on first and second sides of stapling instrument3100′. In various embodiments, surgical stapling instrument 3100′ cancomprise the same, or similar, features to those described in connectionwith surgical stapling instrument 3100 and can be operated in the samemanner, or a similar manner, as instrument 3100 and, as a result, suchdetails are not repeated herein.

In various embodiments, referring to FIG. 205, surgical instrument 3100′can include a rotatable adjustment member 3230′ which can be selectivelypositioned in at least first and second positions so as to providedifferent staple forming heights. In certain embodiments, surgicalinstrument 3100′ can include an actuator 3250′ which can be operablyconnected to adjustment member 3230′ such that actuator 3250′ can moveadjustment member 3230′ between at least its first and second positions.In at least one embodiment, referring to FIG. 206, actuator 3250′ caninclude actuator body 3251′ and grasping portion, or handle, 3252′.Actuator body 3251′ can include an aperture 3258′ which can beconfigured to receive a proximal end 3238′ of adjustment member 3230′such that rotational motion, torque, and/or forces can be transmittedbetween actuator 3250′ and adjustment member 3230′. In at least one suchembodiment, referring to FIG. 214, aperture 3258′ can comprise anon-circular profile and/or a profile which includes one or more flatdrive surfaces configured to transmit rotational motion between actuatorbody 3251′ and actuator 3230′. In certain embodiments, aperture 3258′can be sized and configured to closely receive proximal end 238′ ofactuator 3230′. In at least one embodiment, aperture 3258′ can beconfigured to receive proximal end 238′ in a press-fit and/or snap-fitarrangement. In various embodiments, referring again to FIG. 206, handleportion 3104′ can include one or more slots 3259′ which can beconfigured to permit at least a portion of actuator body 3251′ to extendtherethrough such that grasping portion 3252′ can be assembled toactuator body 3251′ with at least a portion of handle portion 3104′positioned therebetween. In at least one such embodiment, second handleportion 3104′ can further include recess 3253′ which can be configuredsuch that at least a portion, if not all, of grasping portion 3252′ ispositioned within recess 3253′. In certain embodiments, recess 3253′ canbe configured such that grasping portion 3252′ does not extend above thetop surface of second handle portion 3104′ although, in otherembodiments, an upper portion of grasping portion 3252′ can extend abovesecond handle portion 3104, as illustrated in FIG. 208, such thatgrasping portion 3252′ can be easily accessed by a surgeon.

In various embodiments, as outlined above, an adjustment member can berotatable between at least first and second positions in order to adjustthe forming height of staples deployed by a surgical stapler. In certainembodiments, referring to FIG. 206, a surgical stapling instrument caninclude an adjustment member rotatably positioned within an anvilwherein the adjustment member can be configured to limit the relativemovement of a movable anvil portion. In at least one such embodiment,surgical stapling instrument 3100′ can include an anvil plate 3134′which can be slidably retained within anvil channel 3136′ by retention,or guide, pins 3140′, wherein guide pins 3140′ can be configured toallow anvil plate 3134′ to slide upwardly when anvil plate 3134′ comesinto contact with tissue as described above. Referring to FIGS. 205,208, and 209, adjustment member 3230′ can be positionable in a firstposition, or orientation, such that it can limit the upward movement ofanvil plate 3134′ within anvil channel 3136′ and dictate the stapleforming height of the staples. In at least one such embodiment,referring to FIGS. 208 and 209, adjustment member 3230′ can includeopposing first surfaces 3231′ which can be positioned intermediate base3138′ of anvil channel 3136′ and positioning surface 3145′ of anvilplate 3134′ such that, when positioning surface 3145′ contacts one offirst surfaces 3231′, tissue-contacting surface 3148′ of anvil plate3134′ can be positioned a first distance 3234′ away from a datum surface3129′ on anvil 3130′, for example. Correspondingly, forming surfaces3132′ can be positioned a first distance away from a staple cartridgesuch that, when staples are deployed from the staple cartridge, thestaples can be deformed to a first staple height. Further to the above,a first diameter 3241′ can be defined between first surfaces 3231′wherein the first diameter 3241′ can define the maximum upward positionof anvil plate 3134′ within anvil channel 3136′.

As indicated above, adjustment member 3230′ can be rotated in order toadjust the forming height of the staples. In various embodiments,adjustment member 3230′ can be rotated between its first position, ororientation, (FIGS. 208 and 209) and a second position, or orientation(FIGS. 210 and 211). In at least one embodiment, referring to FIGS. 210and 211, handle 3252′ can be rotated in a direction indicated by arrow“A” in order to move adjustment member 3230′ between its first andsecond positions. Similar to the above, when actuator 3230′ is in itssecond position, or orientation, actuator 3230′ can limit the upwardmovement of anvil plate 3134′ within anvil channel 3136′ and dictate thestaple forming height of the staples. In at least one such embodiment,referring to FIGS. 210 and 211, adjustment member 3230′ can includeopposing second surfaces 3232′ which can be positioned intermediate base3138′ and positioning surface 3145′ such that, when positioning surface3145′ contacts one of second surfaces 3232′, tissue-contacting surface3148′ of anvil plate 3134′ can be positioned a second distance 3235′away from datum surface 3129′, for example. Correspondingly, formingsurfaces 3132′ can be positioned a second distance away from a staplecartridge such that, when staples are deployed from the staplecartridge, the staples can be deformed to a second staple height. Invarious embodiments, similar to the above, a second diameter 3242′ canbe defined between second surfaces 3232′, wherein second diameter 3242′can define the maximum upward position of anvil plate 3134′ within anvilchannel 3136′. Although first surfaces 3231′ and second surfaces 3232′can be defined by flat, or at least substantially flat, surfaces, otherembodiments are envisioned in which the first and second surfaces 3231′and 3232′ can include at least partially arcuate, or curved, contours.In any event, referring to FIG. 205, adjustment member 3230′ may includeone or more clearance slots 3240′ which can be configured to provideclearance between actuator 3230′ and retention pins 3140′. Clearanceslots 3240′ can be configured to provide clearance between actuator3230′ and retention pins 3140′ when actuator 3230′ is in its firstposition, second position, and/or any other suitable position.

In various embodiments, further to the above, adjustment member 3230′can be rotated between its first position, or orientation, (FIGS. 208and 209) and a third position, or orientation (FIGS. 212 and 213). In atleast one embodiment, referring to FIGS. 212 and 213, handle 3252′ canbe rotated in a direction indicated by arrow “B” in order to moveadjustment member 3230′ between its first and third positions. Similarto the above, when actuator 3230′ is in its third position, ororientation, actuator 3230′ can limit the upward movement of anvil plate3134′ within anvil channel 3136′ and dictate the staple forming heightof the staples. In at least one such embodiment, referring to FIGS. 212and 213, adjustment member 3230′ can include opposing third surfaces3233′ which can be positioned intermediate base 3138′ and positioningsurface 3145′ such that, when positioning surface 3145′ contacts one ofthird surfaces 3233′, tissue-contacting surface 3148′ of anvil plate3134′ can be positioned a third distance 3236′ away from datum surface3129′, for example. Correspondingly, forming surfaces 3132′ can bepositioned a third distance away from a staple cartridge such that, whenstaples are deployed from the staple cartridge, the staples can bedeformed to a third staple height. In various embodiments, similar tothe above, a third diameter 3243′ can be defined between third surfaces3233′, wherein third diameter 3243′ can define the maximum upwardposition of anvil plate 3134′ within anvil channel 3136′. Referring onceagain to FIGS. 212 and 213, third surfaces 3233′ can be defined by an atleast partially arcuate contour, although other embodiments areenvisioned in which third surfaces 3233′ can include flat, or at leastsubstantially flat, contours. In at least one embodiment, adjustmentmember 3230′ can be configured such that the largest distance, ordiameter, between the arcuate third surfaces 3233′ can be utilized todefine the third staple height.

As described above, referring to FIGS. 208 and 209, adjustment member3230′ can be positioned in a first position, or orientation, to set afirst forming height for the staples deployed by surgical staplinginstrument 3100′. As also described above, referring to FIGS. 210 and211, actuator 3250′ can be utilized to move adjustment member 3230′ intoits second position, or orientation, to set a second forming height forthe staples. To do this, in at least one embodiment, a force can beapplied to handle 3252′ which can cause handle 3252′, and adjustmentmember 3230′ attached thereto, to rotate in a direction indicated byarrow “A”. In at least one embodiment, adjustment member 3230′ and/oractuator 3250′ can be sufficiently retained such that, when adjustmentmember 3230′ is rotated, adjustment member 3230′ can be rotated about anaxis, such as axis 3245′ (FIG. 205), for example. In at least oneembodiment, referring to FIG. 203, the proximal end 3203′ of pusher barassembly 3200′ can include one or more grooves, channels, or recesses3205′ which can be configured to receive and/or retain at least aportion of adjustment member 3230′ and/or actuator 3250′ therein. In anyevent, as illustrated in FIGS. 208-211, the second position, ororientation, of adjustment member 3230′ can allow anvil plate 3134′ toslide a larger distance within anvil channel 3136′ as compared to whenadjustment member 3230′ is in its first position. In at least oneembodiment, as a result, the second staple forming height can be largerthan the first staple forming height. As also described above, referringto FIGS. 212 and 213, actuator 3250′ can be utilized to move adjustmentmember 3230′ into its third position, or orientation, to set a thirdforming height for the staples. To do this, in at least one embodiment,a force can be applied to handle 3252′ which can cause handle 3252′, andadjustment member 3230′ attached thereto, to rotate in a directionindicated by arrow “B”. As illustrated in FIGS. 208, 209, 212, and 213,the third position, or orientation, of adjustment member 3230′ can allowanvil plate 3134′ to slide a smaller distance within anvil channel 3136′as compared to when adjustment member 3230′ is in its first position. Inat least one embodiment, as a result, the first and second stapleforming heights can be larger than the third staple forming height. Inat least one such embodiment, the first position of adjustment member3230′, and actuator 3250′, can represent an intermediate position,wherein adjustment member 3230′ can be selectively moved into its secondand third positions directly from its first position. In effect, thefirst position of adjustment member 3230′ can represent an intermediatestaple height, wherein the second and third staple positions ofadjustment member 3230′ can represent taller and shorter staple heights,respectively. In certain embodiments, referring to FIG. 202, surgicalstapling instrument 3100′ can include one or more indicia thereon whichcan be configured to convey the staple forming heights, or at leastrelative forming heights, that can be selected. For example, secondhandle portion 3104′ can include a first indicium 3245′ which canindicate an intermediate, or first, staple height, a second indicium3246′ which can indicate a taller, or second, staple height, and, inaddition, a third indicium 3247′ which can indicate a shorter, or third,staple height.

In various embodiments, further to the above, one or more of firstsurfaces 3231′, second surfaces 3232′, and third surfaces 3233′ cancomprise or define, or at least partially comprise or define, aperimeter, or circumference, of adjustment member 3230′. As discussedabove, owing to the first, second, and third diameters (3241′, 3242′,and 3243′) defined by the first, second, and third surfaces (3231′,3232′, and 3233′), respectively, the perimeter, or circumference, ofadjustment member 3230′ may be non-circular. In certain embodiments,though, the perimeter, or circumference of adjustment member 3230′, maybe symmetrical, substantially symmetrical, and/or non-symmetrical. Invarious embodiments, further to the above, an adjustment member cancomprise a cam rotatably positioned intermediate base 3138′ of anvil3130′ and adjustment surface 3145′ of anvil plate 3134′, for example. Inat least one such embodiment, one or more of first surfaces 3231′,second surfaces 3232′, and third surfaces 3233′, for example, cancomprise or define a cam profile which, similar to the above, can beconfigured to either positively position anvil plate 3134′ and/orprovide a stop against which anvil plate 3134′ can be positioned. In anyevent, although not illustrated, various embodiments are envisioned inwhich an adjustment member can be slid and rotated in order to set twoor more staple forming heights for staples deployed by a surgicalstapling instrument. In at least one such embodiment, an adjustmentmember can comprise a cam profile which can be defined along the lengthof the adjustment member wherein longitudinal and/or rotational movementcan be utilized to move the cam profile between at least first andsecond positions.

In various embodiments, similar to the above, surgical instrument 3100′can further include a detent mechanism configured to hold, or at leastreleasably hold, actuator 3250′ in position. In at least one embodiment,referring to FIGS. 203 and 204, surgical instrument 3100′ can furtherinclude detent member 3260′ comprising detent body 3261′ and one or moredetent legs 3262′. Referring to FIG. 204, detent body 3261′ can includeone or more grooves, recesses, or channels 3263′ which can be configuredto receive at least a portion of proximal end 3105′ of second handleportion 3104′ therein such that detent member 3260′ can be retained inposition. In at least one such embodiment, proximal end 3105′ canfurther include one or more grooves, channels, or recesses 3265′ whichcan be configured to closely receive detent member 3260′. In certainembodiments, at least a portion of detent body 3261′, such as channel3263′, for example, can be press-fit, snap-fit, and/or otherwisesuitably retained in recess 3265′. As also illustrated in FIG. 204, eachdetent leg 3262′ of detent member 3260′ can include one or moreprojections 3264′ extending therefrom which can be configured to engageactuator body 3251′ and releasably hold actuator 3250′ in position. Inat least one embodiment, referring to FIG. 214, actuator body 3251′ caninclude one or more recesses, or holes, 3269′ which can be configured toreceive a projection 3264′. When a projection 3264′ is positioned withinrecess 3269′, the projection can be configured to hold actuator 3250′ inits first position, for example, until a sufficient force is applied toactuator 3250′ so as to cause the projection 3264′ to be displaced outof recess 3269′. More particularly, the force applied to actuator 3250′can be transmitted to the projection 3264′ and, owing to cooperatingsurfaces between the projection 3264′ and recess 3269′, the detent leg3262′ associated with the projection 3264′ can be flexed or movedproximally to allow actuator body 3251′ to be moved relative thereto. Inorder to accommodate such proximal movement, referring to FIG. 203,recess 3265′ can include elongate portions 3266′ which can each beconfigured to receive at least a portion of legs 3262′ such that legs3262′ can move relative to handle portion 3104′. As actuator 3250′ ismoved into either its second or third position, actuator body 3251′ cancontact a projection 3264′ extending from another leg 3262′ and deflectthe leg 3262′ proximally such that, once actuator 3250′ is in its secondor third positions, the leg 3262′ can spring forward, or distally, suchthat the projection 3264′ can be secured within recess 3269′. In atleast one embodiment, further to the above, the interaction betweenprojections 3264′ and the sidewalls of recess 3269′ can be such thatactuator 3250′ can be securely held in one of its first, second, andthird positions, for example, yet permit actuator 3250′ to be moved upona sufficient application of force. In such embodiments, the detentmember 3260′ can prevent, or at least inhibit, actuator 3250′ and,correspondingly, adjustment member 3230′ from being unintentionallydisplaced.

As discussed above and as shown in FIG. 180, each side flange 3128 offirst handle portion 3102 can include a notch, or recess, 3127, forexample, which can be configured to receive one or more latchprojections 3131, for example, extending from anvil 3130, and/or anyother suitable portion of second handle portion 3104. As also discussedabove, referring primarily to FIGS. 180 and 181, first handle portion3102 can further include latching mechanism 3180 rotatably mountedthereto which can be utilized to engage latch projections 3131 extendingfrom second handle portion 3104 and secure the first and second handleportions 3102, 3104 together. Latching mechanism 3180 can include one ormore latch arms 3188 extending therefrom which can be configured toengage latch projections 3131 and pull and/or secure projections 3131within recesses 3127 as illustrated in FIG. 185. Referring to FIG. 184,at least one of latch arms 3188 can include a distal hook 3189 which canbe configured to wrap around at least a portion of projections 3131 soas to encompass or surround, or at least partially encompass orsurround, projections 3131. In at least one embodiment, latch arms 3188can act as an over-center latch to maintain latching mechanism 3180 inits latched, or closed, position.

In various embodiments, referring now to FIG. 216, each projection 3131can comprise a slot, or groove, 3190 positioned intermediate sidewall3191 and an enlarged end, or head, 3192 of projection 3131, wherein theslot 3190 can be configured to receive at least a portion of latch arm3188. More particularly, in at least one embodiment, the slot 3190 canhave a width which is greater than the width of the latch arm 3188 suchthat, when the latch arm 3188 is engaged with the projection 3131, thelatch arm 3188 can enter into slot 3190. In some circumstances, thewidth of each slot 3190 may be slightly larger than the width of a latcharm 3188 such that the latch arm is closely received within the slot3190. In various circumstances, the slot 3190, the sidewall 3191, andthe head 3192 of projection 3131 can be sized and configured so as toprevent, or at least limit, relative lateral movement, i.e., movementaway from or to the sides of anvil 3130, between latch arm 3188 andprojection 3131. Further to the above, however, the latch arms 3188 canslide longitudinally within the grooves 3190 as the latch arms 333188move the projections 3131 into the recesses 3127 in first portion 3102.Owing to such relative sliding movement between latch arms 3188 andprojections 3131, frictional forces can be generated therebetween whichcan resist the movement of latch arms 3188. In various circumstances,the magnitude of such frictional forces can be significant when thenormal, or perpendicular, contact forces between the latch arms 3188 andthe sidewalls of groove 3190 are large. In many circumstances, as aresult, the operator of the surgical instrument has to overcome thesefrictional forces when actuating clamping mechanism 3180.

In various alternative embodiments, referring now to FIGS. 217 and 218,a surgical instrument can comprise one or more latch projections havinga rotatable bearing which can reduce the magnitude of the frictionforces between the latch arms of a latching mechanism and the latchprojections. In at least one embodiment, an anvil 3330, which can besubstantially similar to anvil 3130 in many respects, can comprise alatch projection 3331 extending from each side thereof, wherein eachlatch projection 3331 can comprise a rotatable bearing 3393. In use, thelatch arms 3188 of latching mechanism 3180, for example, can contact therotatable bearings 3393 in order to position the latch projections 3331in recesses 3127. In various circumstances, the latch arms 3188 canslide across the surface, or outer diameter, of bearings 3393; however,as bearings 3393 can rotate relative to the latch arms 3188, themagnitude of the frictional forces between the latch arms 3188 andprojections 3331 can be lower than the magnitude of the frictionalforces between latch arms 3188 and projections 3131. Owing to such lowerfrictional forces, a lower closing, or clamping, force may be requiredto actuate clamping mechanism 3180, for example.

In various embodiments, referring primarily to FIG. 219, each rotatablebearing 3393 can comprise a circular, or round, outer diameter 3394 and,in addition, a circular, or round, bearing aperture 3395 extendingtherethrough. In certain embodiments, each projection 3331 can furthercomprise a shaft portion 3396 extending from sidewall 3391 and anenlarged end, or head, 3392 extending from shaft portion 3396, wherein,as illustrated in FIG. 209, the shaft portion 3396 can extend throughthe bearing aperture 3395 of rotatable bearing 3393. In variousembodiments, the shaft portion 3396 can comprise a circular, or round,outer diameter which can be closely received within bearing aperture3395 such that there is little, if any, relative radial movementtherebetween. The diameter of the bearing aperture 3395, however, may besufficiently larger than the outer diameter of shaft portion 3396 suchthat bearing 3393 can rotate relative to shaft portion 3396 about anaxis 3399. In various embodiments, the rotatable bearing 3393 can beretained on shaft portion 3396 by the enlarged head 3392. Moreparticularly, in at least one embodiment, the enlarged head 3392 may belarger than, or define a larger diameter than, the diameter of bearingaperture 3395 such that rotatable bearing 3393 cannot slide off the endof shaft portion 3396. In certain embodiments, the sidewall 3391 and thehead 3392 can define a gap distance therebetween and, in addition, thebearing 3393 can comprise a width, wherein the gap distance can belarger than the width of bearing 3393. In at least one embodiment, thegap distance may be slightly larger than the width of bearing 3393 suchthat bearing 3393 does not tilt, or at least substantially tilt,relative to axis 3399, for example.

As discussed above, the latch arms 3188 of latching mechanism 3180 canbe configured to engage bearings 3393 and position bearings 3393 withinrecesses 3127. In various alternative embodiments, referring primarilyto FIG. 218, a surgical instrument can comprise a latching mechanism3380 which can comprise first and second latch arms 3388 extendingtherefrom on opposite sides of anvil 3331 and staple cartridge channel3324. In use, similar to the above, the latch arms 3388 can contactbearings 3393 in order to move bearings 3393 into recesses 3327 instaple cartridge channel 3324 and move anvil 3331 toward staplecartridge channel 3324. Such movement is illustrated with phantom linesin FIG. 219. In various embodiments, each latch arm 3388 can at leastpartially define a groove, or slot, 3397 therein, wherein each slot 3397can be configured to receive a bearing 3393. In at least one embodiment,a slot 3397 can comprise a first drive surface, or sidewall, 3398 awhich can be positioned against bearing 3393 and, as a closing force isapplied to latching mechanism 3380, the latch arm 3388 can apply aclosing force to the bearing 3393. In such circumstances, the bearing3393 can move further into slot 3397 as latching mechanism 3380 isrotated into its closed position. In various circumstances, the slot3397 can further comprise a second drive surface, or sidewall, 3398 bwhich can be positioned against another and/or opposite side of bearing3393 such that an opening force can be applied to the bearing 3393 vialatch arm 3388. As the latching mechanism 3380 is moved into its openposition, the bearing 3393 can move out of slot 3397. In any event, thefirst drive surface 3398 a and the second drive surface 3398 b candefine a slot width therebetween which can be larger than the outsidediameter of bearing 3393 such that bearing 3393 can move within slot3397. In some embodiments, the slot width may be slightly larger thanthe outside diameter of bearing 3393. In at least one embodiment, atleast portions of the first drive surface 3398 a and the second drivesurface 3398 b can be parallel, or at least substantially parallel, toone another. In at least one such embodiment, at least portions of thefirst drive surface 3398 a can be positioned opposite the second drivesurface 3398 b.

As described above, a surgical stapling instrument can be configured todeform one or more surgical staples between a first, undeployed,configuration and a second, deployed, configuration. In variousembodiments, referring now to FIG. 217, a surgical staple, such asstaple 3400, for example, can comprise a base 3402, a first leg, ordeformable member, 3404 extending from base 3402, and, in addition, asecond leg, or deformable member, 3406 extending from base 3402. Incertain embodiments, the base 3402, the first leg 3404, and the secondleg 3406 can be comprised of a continuous wire, wherein, in at least oneembodiment, the first leg 3404 and the second leg 3406 can each be bentin a direction which is perpendicular to the base 3402 prior to staple3400 being inserted into and deformed by a surgical stapler. Moreparticularly, the staple 3400 can be manufactured such that base 3402 isoriented along a baseline 3401 and such that the legs 3404 and 3406 areoriented along lines 3409 and 3411, respectively, which areperpendicular, or at least substantially perpendicular, to the baseline3401. In various embodiments, the first leg 3404 can be positioned at afirst end of base 3402 and the second end 3406 can be positioned at asecond end of base 3402, wherein, in at least one embodiment, a mid-line3403 can be defined which extends through a midpoint of base 3402 andwhich extends in a direction which is perpendicular to baseline 3401.The staple 3400 can be configured such that the base 3402, first leg3404, and second leg 3406 lie, or at least substantially lie, in thesame, or common, plane when the staple 3400 is in its first, orundeployed, configuration. In such embodiments, the baseline 3401, alongwhich the base 3402 is oriented, and the perpendicular lines 3409 and3411, along which the legs 3404 and 3406 are oriented, can lie in thesame plane.

In various embodiments, further to the above, the continuous wirecomprising the base 3402, the first leg 3404, and the second leg 3406can be comprised of titanium and/or stainless steel, for example. In atleast one embodiment, the first leg 3404 can comprise a first end 3405and the second leg 3406 can comprise a second end 3407, wherein the ends3405 and 3407 can each comprise a sharp, or chisel, tip which can beconfigured to puncture bone and/or tissue. In use, the staple 3400 canbe deformed by a surgical stapler in order to capture tissue, forexample, within the staple 3400. In various embodiments, the staple 3400can be deployed from a staple cartridge such that the ends 3405 and 3407of staple legs 3404 and 3406, respectively, contact an anvil positionedopposite the staple 3400. In such circumstances, a first compressiveforce F1 can be applied to the first leg 3404 and a second compressiveforce F2 can be applied to the second leg 3406 while the base 3402 issupported by at least a portion of the staple cartridge. As described ingreater detail below, the anvil can comprise a staple pocket which canapply the first compressive force F1 to the first leg 3404 such that theend 3405 of staple leg 3404 is moved toward the base 3402. Similarly,the staple pocket can apply the second compressive force F2 to thesecond staple leg 3406 such that the end 3407 of staple leg 3404 is alsomoved toward base 3402. In addition to the above, as also discussed ingreater detail below, referring now to FIGS. 228-230, the staple pocketcan bend the first staple leg 3404 to a first side of base 3402 and thesecond staple leg 3406 to a second, or opposite, side of base 3402.

In various embodiments, referring to FIGS. 227 and 228, the first leg3404 of staple 3400 can be bent such that the end 3405 of the first leg3404 is moved toward the base 3402 and toward the second leg 3406 whenthe first leg 3404 is deformed by the first compressive force F1. In atleast one embodiment, the end 3405 can be moved from a first side 3410of midline 3403, as illustrated in FIG. 227, to a second side 3412 ofmidline 3403, as illustrated in FIG. 228. Similarly, the second leg 3406of staple 3400 can be bent such that the end 3407 of the second leg 3406is moved toward the base 3402 and toward the first leg 3404 when thesecond leg 3406 is deformed by the second compressive force F2. In atleast one embodiment, the end 3407 can be moved from a second side 3412of midline 3403, as illustrated in FIG. 227, to a first side 3410 ofmidline 3403, as illustrated in FIG. 228. In the deployed, or deformed,configuration of staple 3400, as illustrated in FIG. 228, the ends 3405and 3407 of staple legs 3404 and 3406 can extend across the midline 4303in such a way that they form an angle therebetween. More particularly,the end 3405 of the first leg 3404, when it is in its deformedconfiguration, can extend along or with respect to a first axis 3414and, similarly, the end 3407 of the second leg 3406, when it is in itsdeformed configuration, can extend along or with respect to a secondaxis 3416 such that the first axis 3414 and the second axis 3416 definean angle 3417 therebetween. In some embodiments, the angle 3417 may beapproximately 90 degrees, for example. In certain embodiments, the angle3417 may be in a range between approximately 0.1 degrees andapproximately 89 degrees, for example. In various embodiments, the angle3417 may be greater than 90 degrees, while, in at least one embodiment,the angle 3417 may be greater than approximately 90 degrees but lessthan 180 degrees, for example.

In various embodiments, further to the above, the first axis 3414 andthe second axis 3416 can, in various embodiments, be oriented, orcrossed, at a transverse angle with respect to each other, i.e., atleast when the staple 3400 is viewed from the side or elevational viewof FIG. 228. More particularly, upon reviewing FIG. 230, it becomesevident that, although axes 3414 and 3416 extend in transversedirections when viewed from the side (FIG. 228), the axes 3414 and 3416may not, in at least one embodiment, actually intersect one another. Insuch embodiments, when viewing the staple 3400 from the top or bottom(FIG. 230), for example, the axes 3414 and 3416 may extend in parallel,or at least substantially parallel, directions. Furthermore, in variousembodiments, the reader will note that the first axis 3414 and thesecond axis 3416 are not perpendicular with baseline 3401. Statedanother way, the end 3405 of first staple leg 3404 and the end 3407 ofsecond staple leg 3406 are not pointing directly downwardly toward base3402 and baseline 3401. In at least one such embodiment, the first axis3414 and the second axis 3416 can each extend at an acute angle withrespect to baseline 3401, for example.

As described above, a surgical instrument can be configured to deformthe staple 3400 of FIG. 227, for example, between an undeformed shape(FIG. 227) and a deformed shape (FIG. 228). In various embodiments, asalso described above, the surgical instrument can comprise an anvilhaving a staple pocket configured to receive and deform at least aportion of the staple. In certain embodiments, referring now to FIG.220, an anvil can comprise a tissue-contacting surface 3501 and aplurality of staple pockets 3500 formed therein, wherein each staplepocket 3500 can be configured to deform a staple 3400. In variousembodiments, each staple pocket 3500 can comprise a longitudinal axis3599 (FIG. 221) and, in addition, a first forming cup 3502 and a secondforming cup 3504 positioned relative to the longitudinal axis 3599. Inuse, the first forming cup 3502 can be configured to receive the firststaple leg 3404 of staple 3400 and the second forming cup 3504 can beconfigured to receive the second staple leg 3406. More particularly, inat least one embodiment, the staple pocket 3500 can be positionedrelative to the staple 3400 such that, as the staple 3400 is ejectedfrom a staple cartridge, for example, the end 3405 of first leg 3404 canenter the first forming cup 3502 and the end 3407 of second leg 3406 canenter the second forming cup 3504. Further to the above, the end 3405 offirst staple leg 3404 can contact the base 3506 of first forming cup3502 such that the first compressive force F1 can be applied to thefirst leg 3404 and, similarly, the end 3407 of second staple leg 3406can contact the base 3508 of second forming cup 3504 such that thesecond compressive force F2 can be applied to the second leg 3406.

In various embodiments, further to the above, the first forming cup 3502can comprise an inside portion 3510 and an outside portion 3512,wherein, when the end 3405 of first staple leg 3404 enters into thefirst forming cup 3502, the end 3405 can enter into the outside portion3512. Upon entering into the outside portion 3512 of forming cup 3502,the end 3405 can contact base 3506 and, owing to a concave curve of base3506, the end 3405 can be directed inwardly toward the inside portion3510. More particularly, referring now to FIGS. 224-226, the base 3506can be curved toward tissue-contacting surface 3501 such that, as thestaple leg 3404 contacts the base 3506, the end 3405 can be directeddownwardly, i.e., away from tissue-contacting surface 3501, and inwardlyalong the curved concave surface toward an inflection point 3595. Invarious embodiments, the inflection point 3595 can represent the pointin which the concave surface of base 3506 will begin to deflect the end3405 of first leg 3404 upwardly toward the tissue-contacting surface3501. In various embodiments, the radius of curvature, r, of the concavesurface can be constant, or at least substantially constant, in thelongitudinal direction along the length thereof as illustrated in FIGS.225 and 226. In certain embodiments, the radius of curvature r of theconcave surface of base 3506 can be consistent across the width of base3506 between a first interior sidewall 3516 and a first exteriorsidewall 3517. In any event, as the end 3405 of first leg 3404 isadvanced into the inside portion 3510 of forming cup 3502, the end 3405can come into contact with a radius transition 3514 positionedintermediate the base 3506 and the first interior sidewall 3516. In suchembodiments, the radius transition 3514 can be configured to direct theend 3405 against the first interior sidewall 3516.

As illustrated in FIG. 221, further to the above, the first interiorsidewall 3516 can be oriented at an angle with respect to staple pocketlongitudinal axis 3599. In certain embodiments, the first interiorsidewall 3516 can be oriented at an acute angle, such as 10 degrees, forexample, with respect to longitudinal axis 3599. In various embodiments,the first interior sidewall 3516 and the longitudinal axis 3599 may beneither perpendicular nor parallel to one another. In any event, thefirst interior sidewall 3516 can extend through the axis 3599 such thata first portion of the first interior sidewall 3516 is positioned on afirst side 3515 of axis 3599 and a second portion of the first interiorsidewall 3516 is positioned on a second side 3517 of axis 3599. Invarious embodiments, as a result, the first interior sidewall 3516 canextend between the first outside portion 3512 and the first insideportion 3510. When the end 3405 of first leg 3404 contacts the firstinterior sidewall 3516, as described above, the end 3405 can be directedalong the first interior sidewall 3516 and away from longitudinal axis3599 such that the staple leg 3404 is bent away from the common plane ofstaple 3400 toward the first side 3515 of axis 3599. As the end 3405 offirst leg 3404 is directed along, or bent by, the first interiorsidewall 3516, as described above, the staple leg 3404 can also bedirected, or bent, by base 3506. Stated another way, the first sidewall3516 and the first base 3506 can co-operate to deform the first stapleleg 3404 such that end 3405 is re-directed toward the base 3402 and, atthe same time, to a first side of the base 3402 as described above. Atsome point during the insertion of first staple leg 3404 into firstforming cup 3502, the end 3405 of first staple leg 3404 can emerge fromthe first inside portion 3510 of first forming cup 3502 and, as thestaple leg 3404 is further deformed by the staple pocket 3500, the end3405 can be directed along the first axis 3414 (FIG. 228) as describedabove.

In various embodiments, further to the above, the first interiorsidewall 3516 can extend along an interior side of the first base 3506,wherein, in at least one embodiment, the first forming cup 3502 canfurther comprise a first exterior sidewall 3517 extending along anopposite side of the first base 3506. In certain embodiments, similar tothe above, the first forming cup 3502 can further comprise a transitionradius 3519 positioned intermediate the base 3506 and the exteriorsidewall 3517. In at least one embodiment, referring now to FIG. 221,the exterior sidewall 3517 can extend in a direction which is parallel,or at least substantially parallel, to the staple pocket longitudinalaxis 3599. As also illustrated in FIG. 221, the first interior sidewall3516 and the first exterior sidewall 3517 can extend in directions whichare transverse to one another. In at least one embodiment, the interiorsidewall 3516 can extend at an acute angle, such as approximately 15degrees, for example, with respect to the exterior sidewall 3517. Invarious embodiments, as a result, the outside portion 3512 of firstforming cup 3502 can be wider than the inside portion 3510. In at leastone such embodiment, the width of the outside portion 3512 and theinside portion 3510 can taper between a first width and a second width.

In various embodiments, referring once again to FIG. 221, the outsideportion 3512 of first forming cup 3502 can comprise a first outside wall3513 which can extend in a direction which is perpendicular to the firstexterior wall 3517 and/or the longitudinal axis 3599 and can define theoutermost portion of forming cup 3502. In at least one embodiment,further to the above, the width of the first outside wall 3513 can besuch that the outside portion 3512 can capture the end 3405 of first leg3404 and guide it into the inside portion 3510 of cup 3502 as describedabove. In at least one such embodiment, the first outside wall 3513 canbe at least as twice as wide as the diameter of the first leg 3404. Incertain embodiments, the first forming cup 3502 can further comprise achanneling surface 3528 surrounding the first inner portion 3510 and thefirst outer portion 3512 which can be configured to guide the staple leg3404 into and/or out of the forming cup 3502. In various embodiments,the inside portion 3510 can further comprise an inside wall 3511 whichcan define the innermost portion of forming cup 3502. Similar to theabove, the inside wall 3511 can also define the narrowest portion offorming cup 3502. In at least one embodiment, the width of the insidewall 3511 may be the same, or at least substantially the same, as thediameter of first leg 3404 such that the inside wall 3511 can controlthe location in which the end 3405 emerges from staple forming cup 3502.

In various embodiments, further to the above, the second forming cup3504 can comprise an inside portion 3520 and an outside portion 3522,wherein, when the end 3407 of second staple leg 3406 enters into thesecond forming cup 3504, the end 3407 can enter into the outside portion3522. Upon entering into the outside portion 3522 of forming cup 3504,the end 3407 can contact base 3508 and, owing to a concave curve of base3508, the end 3407 can be directed inwardly toward the inside portion3520. More particularly, similar to the above, the base 3508 can becurved toward tissue-contacting surface 3501 such that, as the stapleleg 3406 contacts the base 3508, the end 3407 can be directeddownwardly, i.e., away from tissue-contacting surface 3501, and inwardlyalong the curved concave surface toward an inflection point 3596. Invarious embodiments, the inflection point 3596 can represent the pointin which the concave surface of base 3508 will begin to deflect the end3407 of second leg 3406 upwardly toward the tissue-contacting surface3501. In various embodiments, the radius of curvature, r, of the concavesurface can be constant, or at least substantially constant, in thelongitudinal direction along the length thereof, similar to the base3506 of first forming cup 3502 illustrated in FIGS. 225 and 226. In anyevent, as the end 3407 of second leg 3406 is advanced into the insideportion 3520 of forming cup 3504, the end 3407 can come into contactwith a radius transition 3524 positioned intermediate the base 3508 anda second interior sidewall 3526. In such embodiments, the radiustransition 3524 can be configured to direct the end 3407 against thesecond interior sidewall 3526.

As illustrated in FIG. 221, further to the above, the second interiorsidewall 3526 can be oriented at an angle with respect to staple pocketlongitudinal axis 3599. In certain embodiments, the second interiorsidewall 3526 can be oriented at an acute angle, such as 10 degrees, forexample, with respect to longitudinal axis 3599. In various embodiments,the second interior sidewall 3526 and the longitudinal axis 3599 may beneither perpendicular nor parallel to one another. In any event, thesecond interior sidewall 3526 can extend through the axis 3599 such thata first portion of the second interior sidewall 3526 is positioned on afirst side 3515 of axis 3599 and a second portion of the second interiorsidewall 3526 is positioned on a second side 3517 of axis 3599. Invarious embodiments, as a result, the second interior sidewall 3526 canextend between the second outside portion 3522 and the second insideportion 3520. When the end 3407 of second leg 3406 contacts the interiorsidewall 3526, as described above, the end 3407 can be directed alongthe interior sidewall 3526 such that the staple leg 3406 is bent awayfrom the common plane of staple 3400 toward the second side 3517 of axis3599. As the end 3407 of second leg 3406 is directed along, and bent by,the interior sidewall 3526, as described above, the staple leg 3406 canalso be directed, and bent, by base 3508. Stated another way, the secondinterior sidewall 3526 and the second base 3508 can co-operate to deformthe second staple leg 3406 such that end 3407 is re-directed toward thebase 3402 and, at the same time, toward a second, or opposite, side ofthe base 3402 as described above. At some point during the insertion ofsecond staple leg 3406 into second forming cup 3504, the end 3407 ofsecond staple leg 3406 can emerge from the second inside portion 3520 ofsecond forming cup 3504 and, as the staple leg 3406 is further deformedby the staple pocket 3500, the end 3407 can be directed along the secondaxis 3416 (FIG. 228) as described above.

In various embodiments, further to the above, the second interiorsidewall 3526 can extend along an interior side of the second base 3508,wherein, in at least one embodiment, the second forming cup 3504 canfurther comprise a second exterior sidewall 3527 extending along anopposite side of the second base 3508. In certain embodiments, similarto the above, the second forming cup 3504 can further comprise atransition radius 3529 positioned intermediate the base 3508 and theexterior sidewall 3527. In at least one embodiment, referring now toFIG. 221, the exterior sidewall 3527 can extend in a direction which isparallel, or at least substantially parallel, to the staple pocketlongitudinal axis 3599. As also illustrated in FIG. 221, the secondinterior sidewall 3526 and the second exterior sidewall 3527 can extendin directions which are transverse to one another. In at least oneembodiment, the interior sidewall 3526 can extend at an acute angle,such as approximately 15 degrees, for example, with respect to theexterior sidewall 3527. In various embodiments, as a result, the outsideportion 3522 of second forming cup 3504 can be wider than the insideportion 3520. In at least one such embodiment, the width of the outsideportion 3522 and the inside portion 3520 can taper between a first widthand a second width.

In various embodiments, referring once again to FIG. 221, the outsideportion 3522 of second forming cup 3504 can comprise a second outsidewall 3523 which can extend in a direction which is perpendicular to thesecond exterior wall 3527 and/or the longitudinal axis 3599 and candefine the outermost portion of forming cup 3504. In at least oneembodiment, further to the above, the width of the second outside wall3523 can be such that the outside portion 3522 can capture the end 3407of second leg 3406 and guide it into the inside portion 3520 of cup 3504as described above. In at least one such embodiment, the second outsidewall 3523 can be at least as twice as wide as the diameter of the secondleg 3406. In certain embodiments, the second forming cup 3504 canfurther comprise a channeling surface 3529 surrounding the second innerportion 3520 and the second outer portion 3522 which can be configuredto guide the staple leg 3406 into and/or out of the forming cup 3504. Invarious embodiments, the inside portion 3520 can further comprise aninside wall 3521 which can define the innermost portion of forming cup3504. Similar to the above, the inside wall 3521 can also define thenarrowest portion of forming cup 3504. In at least one embodiment, thewidth of the inside wall 3521 may be the same, or at least substantiallythe same, as the diameter of second leg 3406 such that the inside wall3521 can control the location in which the end 3407 emerges from stapleforming cup 3504.

As discussed above, referring again to FIGS. 221-223, the first formingcup 3502 can comprise a first interior sidewall 3516 and the secondforming cup 3504 can comprise a second interior sidewall 3526. Asillustrated in FIG. 221, the first inside portion 3510 of forming cup3502 can be positioned in close proximity to, or close relation to, thesecond inside portion 3520 of forming cup 3504 such that the firstinterior sidewall 3516 can be positioned adjacent to the second interiorsidewall 3526. In at least one embodiment, the first interior portion3510, or at least a substantial portion thereof, can be offset from thestaple pocket longitudinal axis 3599 in the first direction 3515 whilethe second interior portion 3520, or at least a substantial portionthereof, can be offset from the longitudinal axis 3599 in the seconddirection 3517. In various embodiments, the staple pocket 3500 cancomprise a wall 3530 positioned intermediate the first inside portion3510 and the second inside portion 3520, wherein a first side of wall3530 can comprise the first interior sidewall 3516 and wherein a secondside of wall 3530 can comprise the second interior sidewall 3526. In atleast one such embodiment, the first interior sidewall 3516 can beparallel, or at least substantially parallel to, the second interiorsidewall 3526. More particularly, in at least one embodiment, the firstinterior sidewall 3516 can define a first plane and the second interiorsidewall 3526 can define a second plane, wherein the first plane and thesecond plane can be parallel, or at least substantially parallel, to oneanother. In various embodiments, referring again to FIGS. 222 and 223,the first interior sidewall 3516 can be perpendicular, or at leastsubstantially perpendicular, to the tissue-contacting surface 3501 and,similarly, the second interior sidewall 3526 can be perpendicular, or atleast substantially perpendicular, to the tissue-contacting surface3501.

In various embodiments, further to the above, the first interiorsidewall 3516 can comprise a first vertical portion 3516 a which isperpendicular, or at least substantially perpendicular, to thetissue-contacting surface 3501. In at least one embodiment, the firstvertical portion 3516 a can extend through, or transect, thelongitudinal axis 3599. In various embodiments, the first verticalportion 3516 a can extend along the entirety of, or only a portion of,the first interior sidewall 3516. Similarly, the second interiorsidewall 3526 can comprise a second vertical portion 3526 a which isperpendicular, or at least substantially perpendicular, to thetissue-contacting surface 3501. In at least one embodiment, such asecond vertical portion 3526 a can extend through, or transect, thelongitudinal axis 3599. In various embodiments, the second verticalportion 3526 a can extend along the entirety of, or only a portion of,the second interior sidewall 3526. During the deployment of staple 3400,further to the above, the end 3405 of first leg 3404 can be in contactwith the first vertical portion 3516 a of first interior sidewall 3516at the same time the end 407 of second leg 3406 is in contact with thesecond vertical portion 3526 a of second interior sidewall 3526. In suchcircumstances, the first vertical portion 3516 a and the second verticalportion 3526 a can comprise a vertical trap. More particularly, thevertical portions 3516 a and 3526 a can co-operate to control, deflect,and bend the staple legs 3404 and 3406 in opposite directions, i.e., indirections to the sides of a common plane, as described above, when thelegs 3404 and 3406 come into contact with the interior sidewalls 3516and 3526 of forming cups 3502 and 3504, respectively. For example,referring again to FIG. 230, the first vertical portion 3516 a can beconfigured to deflect and bend the staple leg 3404 to a first side ofbase 3402 and the second vertical portion 3526 a can be configured todeflect and bend the staple leg 3406 to a second, or opposite, side ofbase 3402.

In various embodiments, further to the above, the vertical trapcomprising vertical portions 3516 a and 3526 a can extend along theentire length of the first and second interior sidewalls 3516 and 3526,while, in other embodiments, the vertical trap may extend along only aportion of the sidewalls 3516 and 3526. In at least one embodiment, thevertical trap can be approximately 0.05 inches long, i.e., the overlapof the first vertical surface 3516 a and the second vertical surface3526 a can be approximately 0.05 inches, for example, along the lengthsof interior surfaces 3516 and 3526. In various embodiments, the lengthof the vertical trap can be between approximately 0.03 inches andapproximately 0.10 inches, for example. In certain embodiments, thelength of the vertical trap can be approximately twice the radius ofcurvature (r) of the curved concave surface of base 3506, for example.In various embodiments, the length of the vertical trap can beapproximately equal to the radius of curvature (r) of base 3506, forexample. In at least one embodiment, the length of the vertical trap canbe between approximately 0.5*r and approximately 2*r, for example. Invarious embodiments, further to the above, the vertical trap can extendthrough the longitudinal axis 3599 of staple pocket 3500 such that, inat least one embodiment, at least a portion of the vertical trap can bepositioned on a first side and/or a second side of axis 3599. In certainembodiments, the vertical trap can extend through the central portionsof the first and second forming cups 3502 and 3504.

In various embodiments, the first interior sidewall 3516 can furthercomprise a first angled portion which, in at least one embodiment, canbe oriented at an acute angle with respect to the tissue-contactingsurface 3501. In at least one such embodiment, the first angled portioncan be positioned outwardly with respect to the first vertical portion3516 a. In certain embodiments, the first interior sidewall 3516 cancomprise an angled portion positioned toward the outside portion 3512which can become progressively more perpendicular toward the insideportion 3510 of the first forming cup 3502 until the angled portiontransitions into the first vertical portion 3516 a. In variousembodiments, the second interior sidewall 3526 can further comprise asecond angled portion which, in at least one embodiment, can be orientedat an acute angle with respect to the tissue-contacting surface 3501. Inat least one such embodiment, the second angled portion can bepositioned outwardly with respect to the second vertical portion 3526 a.In certain embodiments, the second interior sidewall 3526 can comprisean angled portion positioned toward the outside portion 3522 which canbecome progressively more perpendicular toward the inside portion 3520of the second forming cup 3504 until the angled portion transitions intothe second vertical portion 3526 a.

In various embodiments, referring now to FIG. 230A, the staple pocket3500 can be configured to deform the first staple leg 3404 such that thefirst end 3405 is deflected a first distance X1 from baseline 3401.Similarly, the second staple leg 3406 can be deformed such that thesecond end 3407 is deflected a second distance X2 from baseline 3401. Incertain embodiments, the distance X1 and the distance X2 can be thesame, or at least substantially the same. In various other embodiments,the distances X1 and X2 can be different. In at least one suchembodiment, the first leg 3404 can be deformed such that the first end3405 is positioned closer to base 3402 than the second end 3407, forexample. In such embodiments, the first axis 3414 of deformed staple leg3404 and the second axis 3416 of deformed staple leg 3406 may benon-parallel. More particularly, in at least one embodiment, the firstaxis 3414 can extend at a first angle with respect to baseline 3401 andthe second axis 3416 can extend at a second angle with respect tobaseline 3401 wherein the second angle is different than the firstangle. In various embodiments, the first leg 3404 and the second leg3406 can extend across midline 3403 at different angles. In certainother embodiments, the first leg 3404 and the second leg 3406 can beextend at different angles with respect to baseline 3401 although one orboth of the legs 3404 and 3406 may not extend across the midline 3403.

In various embodiments, further to the above, a surgical stapler cancomprise a staple pocket which can be configured to deform one stapleleg of staple 3400 such that it lies within, or substantially within, acommon plane with base 3402 and, in addition, deform the other stapleleg of staple 3400 to a side of base 3402 as described above. In atleast one embodiment, the first leg 3404 can be deformed such that itextends through midline 3403 in a direction which is co-planar, or atleast substantially co-planar, with base 3402 and, in addition, thesecond leg 3406 can be deformed such that it extends through midline3403 in a direction which is transverse to the plane. Stated anotherway, in at least one embodiment, axis 3414 and baseline 3401 of staple3400 can be coplanar, or at least nearly co-planar, with one anotherwhile second axis 3416 can extend in a direction which extends throughsuch a plane. In certain embodiments, at least one of the first leg 3404and the second leg 3406 may not extend through the midline 3403.

In various embodiments, further to the above, the staple pocket 3500 canbe configured to deform the staple legs 3404 and 3406 of staple 3400simultaneously, or at least substantially simultaneously. In at leastone embodiment, the base 3506 of first forming cup 3502 can contact end3405 of first staple leg 3404 at the same time, or at leastsubstantially the same time, that the base 3508 of second forming cup3504 contacts end 3407 of second staple leg 3406. In certain otherembodiments, a staple pocket can be configured to deform the staple legs3404 and 3406 sequentially. In at least one such embodiment, a firstforming cup can be brought into contact with the first staple leg 3404before a second forming cup is brought into contact with the secondstaple leg 3406, for example. In various alternative embodiments,although not illustrated, a surgical staple can comprise more than twostaple legs, such as three staple legs or four staple legs, for example,and a staple pocket can comprise a corresponding quantity of stapleforming cups for deforming the staple legs.

In various embodiments, further to the above, the wire comprising thesurgical staple 3400 can comprise a circular, or at least substantiallycircular, cross-section. In various other embodiments, referring now toFIGS. 231-234, a surgical staple, such as staple 3600, for example, cancomprise a non-circular cross-section. In at least one embodiment, thestaple 3600 can comprise a base 3602, a first leg 3604, and a second leg3606, wherein the base 3602 and legs 3604 and 3606 can be comprised of acontinuous wire. In various embodiments, the continuous wire cancomprise a rectangular cross-section, for example. In at least oneembodiment, referring to FIG. 234, the rectangular cross-section cancomprise a base (b) and a height (h), wherein the base (b) can bedefined relative to a central lateral axis (x), and wherein the height(h) can be defined relative to a central longitudinal axis (y). Invarious circumstances, the rectangular cross-section can be defined ashaving two moments of inertia, i.e., a first moment of inertia (Ix)defined with respect to axis (x) and a second moment of inertia (Iy)defined with respect to axis (y). In at least one circumstance, thefirst moment of inertia (Ix) can be calculated as (b*h{circumflex over( )}3)/12 while the second moment of inertia (Iy) can be calculated as(h*b{circumflex over ( )}3)/12. Although staple 3600 comprises arectangular, or at least substantially rectangular cross-section, anyother suitable non-circular cross-section can be utilized, such asoblate, elliptical, and/or trapezoidal cross-sections, for example.

As illustrated in FIG. 234, the base (b) of surgical staple 3600 islarger than the height (h) and, in view of the above, the moment ofinertia (Iy) of the rectangular cross-section is larger than the momentof inertia (Ix). In various embodiments, as a result, the moment ofinertia ratio, i.e., Iy/Ix, of the rectangular cross-section can begreater than 1.0 In certain embodiments, the moment of inertia ratio canbe between approximately 2.0 and approximately 2.7, for example. Incertain other embodiments, the moment of inertia ratio can be betweenapproximately 1.1 and approximately 3.0, for example. As a result of theabove, the leg 3604 is more likely to bend about axis (x) than aboutaxis (y) when a force, such as compressive load F1, for example, isapplied to the leg 3604. In any event, absent all other considerations,the leg 3604, in such embodiments, is more likely to bend within acommon plane defined by the staple 3600 when it is in its undeformedstate than bend to a side of staple base 3602. In various embodiments,however, a surgical stapler comprising an anvil and staple pocket inaccordance with the embodiments described herein, such as staple pocket3500, for example, can be utilized to cause the legs 3604 and 3606 ofstaple 3600 to bend out of their common plane when they are deformed. Insuch embodiments, this lateral deflection can occur despite the factthat the moment of inertia Iy, which resists such twisting, is greaterthan the moment of inertia Ix. As illustrated in FIG. 233, the first leg3604 of staple 3600 can be deformed such that it is bent relative toboth axis (x) and axis (y) of its cross-section and, as a result, thefirst staple leg 3604 can be twisted or deformed such that the end 3605of first staple leg 3604 is positioned on a first side of base 3602.Similarly, the second leg 3606 can be deformed such that it is bentrelative to both axis (x) and axis (y) of its cross-section and, as aresult, the second staple leg 3606 can be twisted or deformed such thatthe end 3607 of second staple leg 3606 is positioned on a second side ofbase 3602.

In various embodiments, referring now to FIG. 235, a surgical staple,such as surgical staple 3700, for example, can comprise a base 3702 and,in addition, a first leg 3704 and a second leg 3706 extending from base3702. In certain embodiments, similar to the above, the base 3702, thefirst leg 3704, and the second leg 3706 can lie, or at leastsubstantially lie, in a common plane when the staple 3700 is anundeformed, or undeployed, configuration, i.e., a configuration prior tobeing deformed by an anvil of a surgical stapler, for example. In thedeformed or deployed configuration of staple 3700, as illustrated inFIG. 235, the first leg 3704 can be deformed such that end 3705 pointstoward base 3702 and second leg 3706. More particularly, in at least oneembodiment, the end 3705 can lie along, or with respect to, a first axis3714 which is oriented at angle with respect to midline 3703. Similarly,the second leg 3706 can be deformed such that end 3707 points towardbase 3702 and first leg 3704. More particularly, in at least oneembodiment, the end 3707 can lie along, or with respect to, a secondaxis 3716 which is oriented at angle with respect to midline 3703. Invarious embodiments, the ends 3705 and 3707 of legs 3704 and 3706 maynot cross mid-line 3703. In certain embodiments, similar to the above,the end 3705 of first leg 3704 may be deformed such that it extends to afirst side of base 3702 and the end 3707 of second leg 3706 may bedeformed such that it extends to a second, or opposite, side of base3702 such that legs 3704 and 3706 are not entirely positioned in-planewith base 3702 in their deformed configuration, for example.

In various embodiments, a surgical staple, such as staple 3800 (FIG.236), for example, can comprise a base 3802, a first leg 3804, and asecond leg 3806, wherein the staple 3800 can comprise a substantiallyU-shaped configuration in its undeformed, or undeployed, configuration.In at least one such embodiment, legs 3804 and 3806 can extend in aperpendicular, or at least substantially perpendicular, direction withrespect to base 3802. In various circumstances, the staple 3800 can bedeformed into a B-shaped configuration as illustrated in FIG. 236. In atleast one such embodiment, the first leg 3804 can be bent downwardlytoward base 3802 such that axis 3814 extending through end 3805 isperpendicular, or at least substantially perpendicular, to baseline3801. Similarly, the second leg 3806 can be bent downwardly toward base3802 such that axis 3816 extending through end 3807 is perpendicular, orat least substantially perpendicular, to baseline 3801. In at least onesuch circumstance, the legs 3804 and 3806 can be bent such that axes3814 and 3816 are parallel, or at least substantially parallel, to oneanother. In various embodiments, referring again to FIG. 236, the staplelegs 3804 and 3806 can be deformed such that they do not crosscenterline 3803. The staple legs 3804 and 3806 can be deformed such thatthey remain in-plane, or at least substantially in-plane, with base3802.

Various examples described below are envisioned which incorporate one ormore aspects of the various embodiments described above. Such examplesare exemplary and various aspects of various embodiments described inthis application can be combined in a single embodiment. In each of theexamples described below, the surgical staple can comprise a basedefining a baseline, a first leg and a second leg which extend from thebase, and a midline midway between the first leg and the second leg.

Example 1

A surgical staple can be deformed such that

First Leg Second Leg Crosses the midline (FIG. 228) Crosses the midline(FIG. 228) Extends in-plane, or Extends out of plane with thesubstantially in-plane, with base (FIG. 230) the base (FIG. 236) The endextends in a The end extends in a non-perpendicular directionnon-perpendicular direction with the baseline (FIG. 228) with thebaseline (FIG. 228)

Example 2

A surgical staple can be deformed such that

First Leg Second Leg Crosses the midline (FIG. 228) Crosses the midline(FIG. 228) Extends out of plane with the Extends out of plane with thebase (FIG. 230) to the same base (FIG. 230) to the same side of the baseas the second side of the base as the first leg, the distance X1 beingleg, the distance X1 being different than X2 (FIG. 230A) different thanX2 (FIG. 230A) The end extends in a The end extends in anon-perpendicular direction non-perpendicular direction with thebaseline (FIG. 228) with the baseline (FIG. 228)

Example 3

A surgical staple can be deformed such that

First Leg Second Leg Does not cross the midline Does not cross themidline (FIG. 235) (FIG. 235) Extends out of plane with the Extends outof plane with the base (FIG. 230) to a first side base (FIG. 230) to asecond of the base, the distance X1 side of the base, the distance beingdifferent than X2 X1 being different than X2 (FIG. 230A) (FIG. 230A) Theend extends in a The end extends in a non-perpendicular directionnon-perpendicular direction with the baseline (FIG. 228) with thebaseline (FIG. 228)

Example 4

A surgical staple can be deformed such that

First Leg Second Leg Does not cross the midline Does not cross themidline (FIG. 235) (FIG. 235) Extends out of plane with the Extends outof plane with the base (FIG. 230) to the same base (FIG. 230) to thesame side of the base as the second side of the base as the second leg,the distance X1 being leg, the distance X1 being different than X2 (FIG.230A) different than X2 (FIG. 230A) The end extends in a The end extendsin a non-perpendicular direction non-perpendicular direction with thebaseline (FIG. 228) with the baseline (FIG. 228)

Example 5

A surgical staple can be deformed such that

First Leg Second Leg Does not cross the midline Does not cross themidline (FIG. 235) (FIG. 235) Extends in-plane, or Extends out of planewith the substantially in-plane, with base (FIG. 230) the base (FIG.236) The end extends in a The end extends in a perpendicular directionwith non-perpendicular direction the baseline (FIG. 236) with thebaseline (FIG. 228)

Example 6

A surgical staple can be deformed such that

First Leg Second Leg Crosses the midline (FIG. 228) Does not cross themidline (FIG. 235) Extends out of plane with the Extends out of planewith the base (FIG. 230) to a first side base (FIG. 230) to a second ofthe base, the distance X1 side of the base, the distance being differentthan X2 X1 being different than X2 (FIG. 230A) (FIG. 230A) The endextends in a The end extends in a non-perpendicular directionnon-perpendicular direction with the baseline (FIG. 228) with thebaseline (FIG. 228)

Example 7

A surgical staple can be deformed such that

First Leg Second Leg Crosses the midline (FIG. 228) Does not cross themidline (FIG. 235) Extends out of plane with the Extends out of planewith the base (FIG. 230) to the same base (FIG. 230) to the same side ofthe base as the second side of the base as the second leg, the distanceX1 being leg, the distance X1 being different than X2 (FIG. 230A)different than X2 (FIG. 230A) The end extends in a The end extends in anon-perpendicular direction non-perpendicular direction with thebaseline (FIG. 228) with the baseline (FIG. 228)

Example 8

A surgical staple can be deformed such that

First Leg Second Leg Crosses the midline (FIG. 228) Does not cross themidline (FIG. 235) Extends out of plane with the Extends in-plane, orbase (FIG. 230) substantially in-plane, with the base (FIG. 236) The endextends in a The end extends in a non-perpendicular directionperpendicular direction to with the baseline (FIG. 228) the baseline(FIG. 236)

Example 9

A surgical staple can be deformed such that

First Leg Second Leg Crosses the midline (FIG. 228) Does not cross themidline (FIG. 235) Extends in-plane, or Extends out of plane with thesubstantially in-plane, with base (FIG. 230) the base (FIG. 236) The endextends in a The end extends in a non-perpendicular directionnon-perpendicular direction with the baseline (FIG. 228) with thebaseline (FIG. 228)

Several of the deformed staples described above comprise one or morestaple legs which cross the mid-line of the staple base. In variousembodiments, as a result, the deformed staple legs may at leastpartially overlap with one another. More particularly, the deformedstaple legs, when viewed from the side, may co-operate to traverse thestaple base from one end to the other leaving no gap therebetween. Suchembodiments can be particularly useful, especially when used to staplevascular tissue. More specifically, the overlapping staple legs cancompress blood vessels within the tissue regardless of where the bloodvessels extend through the staple. Staples having gaps between the legs,or legs which do not extend along the entire length of the staple basewhen deformed, may not be able to properly compress every blood vesselin the tissue and, as a result, one or more blood vessels may leak.

In various embodiments, further to the above, a surgical instrument canbe configured to deploy a plurality of staples 3400 in the mannerdescribed above and illustrated in FIGS. 228-230. In at least one suchembodiment, the surgical stapler can deploy the staples 3400 in asequential manner along a staple path and/or in a simultaneous manner,for example. In certain embodiments, a surgical instrument can beconfigured to deploy a plurality of staples 3600 in the manner describedabove and illustrated in FIG. 233. In at least one such embodiment,similar to the above, the surgical stapler can deploy the staples 3600in a sequential manner along a staple path and/or in a simultaneousmanner, for example. In various embodiments, further to the above, asurgical instrument can be configured to deploy a plurality of staples3700 in the manner described above and illustrated in FIG. 235. In atleast one such embodiment, the surgical stapler can deploy the staples700 in a sequential manner along a staple path and/or in a simultaneousmanner, for example.

In various embodiments, further to the above, a surgical staple can becomprised of titanium, such as titanium wire, for example. In certainembodiments, a surgical staple can be comprised of an alloy comprisingtitanium, aluminum, and/or vanadium, for example. In at least oneembodiment, the surgical staple can be comprised of surgical stainlesssteel and/or an alloy comprised of cobalt and chromium, for example. Inany event, the surgical staple can be comprised of metal, such astitanium, and a metal oxide outer surface, such as titanium oxide, forexample. In various embodiments, the metal oxide outer surface can becoated with a material. In certain embodiments, the coating material canbe comprised of polytetrafluoroethylene (PTFE), such as Teflon®, and/ora tetrafluoroethylene (TFE) such as ethylene-tetrafluoroethylene (ETFE),perfluroralkoxyethylene-tetrafluoroethylene (PFA), and/or FluorinatedEthylene Propylene (FEP), for example. Certain coatings can comprisesilicon. In various embodiments, such coating materials can prevent, orat least inhibit, further oxidation of the metal. In certainembodiments, the coating materials can provide one or more lubricioussurfaces against which the anvil, or staple pockets, can contact thestaples in order to reduce the friction force therebetween. In variouscircumstances, lower friction forces between the staples and the staplepockets can reduce the force required to deform the staples.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

What is claimed is:
 1. An end effector for use with a surgicalinstrument including a closure driver, the end effector comprising: afirst jaw comprising an anvil including at least one staple pocket thatdefines a longitudinal axis, wherein the staple pocket comprises: afirst cup; and a second cup; and a second jaw comprising a staplecartridge, wherein the end effector is transitionable between an openconfiguration and a closed configuration in response to a closure motionby the closure driver, wherein the first jaw and the second jawcooperate to grasp tissue in the closed configuration, and wherein thestaple cartridge comprises: staples deployable from the staple cartridgeinto the tissue, wherein each of the staples comprises: a crown; a firstdeformable member extending from the crown; and a second deformablemember extending from the crown, wherein the first deformable member andthe second deformable member define a common plane prior to beingdeformed by the anvil, wherein the first cup comprises a first surfaceshaped to bend the first deformable member toward a first side of thecommon plane, and wherein the second cup comprises a second surfaceshaped to bend the second deformable member toward a second side of thecommon plane opposite the first side; and a sled movable to deploy thestaples into the tissue, wherein the sled comprises a camming surfacemovable into a direct engagement with the crown to motivate the firstdeformable member to contact the first surface of the first cup and thesecond deformable member to contact the second surface of the secondcup.
 2. The end effector of claim 1, wherein the first deformable membercomprises a first end, wherein the second deformable member comprises asecond end, and wherein the first end is deformed in a first direction,and wherein the second end is deformed in a second direction transverseto the first direction.
 3. The end effector of claim 2, wherein an angleis defined between the first direction and the second direction, andwherein the angle is approximately 90 degrees.
 4. The end effector ofclaim 2, wherein an angle is defined between the first direction and thesecond direction, and wherein the angle is between approximately 0.1degrees and approximately 90 degrees.
 5. The end effector of claim 1,wherein the first cup comprises a first inner surface at least partiallypositioned on a first side of the longitudinal axis, and wherein thesecond cup comprises a second inner surface at least partiallypositioned on a second side of the longitudinal axis.
 6. The endeffector of claim 5, wherein the first inner surface defines a firstplane oriented at an angle with respect to the longitudinal axis, andwherein the second inner surface defines a second plane oriented at anangle with respect to the longitudinal axis.
 7. The end effector ofclaim 5, wherein the first cup and the second cup are separated by asidewall, wherein a first side of the sidewall comprises the first innersurface, and wherein a second side of the sidewall comprises the secondinner surface.
 8. An end effector for use with a surgical instrumentincluding a closure driver, the end effector comprising: a first jawcomprising an anvil including at least one staple pocket that defines alongitudinal axis, wherein the staple pocket comprises: a first cup; anda second cup; and a second law comprising a staple cartridge, whereinthe end effector is transitionable between an open configuration and aclosed configuration in response to a closure motion by the closuredriver, wherein the first law and the second law cooperate to grasptissue in the closed configuration, and wherein the staple cartridgecomprises: staples deployable from the staple cartridge into the tissue,wherein each of the staples comprises: a crown comprising asled-engagement surface; a first leg extending from the crown; and asecond leg extending from the crown, wherein the first leg and thesecond leg define a common plane prior to being deformed by the anvil,wherein the first cup comprises a first surface shaped to bend the firstleg toward a first side of the common plane, and wherein the second cupcomprises a second surface shaped to bend the second leg toward a secondside of the common plane opposite the first side; and a sled comprisinga crown-engagement surface, wherein the crown-engagement surface ismovable to motivate the sled-engagement surface of the crown to causethe first leg to contact the first surface of the first cup and thesecond leg to contact the second surface of the second cup.
 9. The endeffector of claim 8, wherein the first leg comprises a first end,wherein the second leg comprises a second end, and wherein the first endis deformed in a first direction, and wherein the second end is deformedin a second direction transverse to the first direction.
 10. The endeffector of claim 9, wherein an angle is defined between the firstdirection and the second direction, and wherein the angle isapproximately 90 degrees.
 11. The end effector of claim 9, wherein anangle is defined between the first direction and the second direction,and wherein the angle is between approximately 0.1 degrees andapproximately 90 degrees.
 12. The end effector of claim 8, wherein thefirst cup comprises a first inner surface at least partially positionedon a first side of the longitudinal axis, and wherein the second cupcomprises a second inner surface at least partially positioned on asecond side of the longitudinal axis.
 13. The end effector of claim 12,wherein the first inner surface defines a first plane oriented at anangle with respect to the longitudinal axis, and wherein the secondinner surface defines a second plane oriented at an angle with respectto the longitudinal axis.
 14. The end effector of claim 12, wherein thefirst cup and the second cup are separated by a sidewall, wherein afirst side of the sidewall comprises the first inner surface, andwherein a second side of the sidewall comprises the second innersurface.
 15. An end effector for use with a surgical instrumentincluding a closure driver, the end effector comprising: a first jawcomprising an anvil including at least one staple pocket that defines alongitudinal axis, wherein the staple pocket comprises: a first cup; anda second cup; and a second jaw comprising a staple cartridge, whereinthe end effector is transitionable between an open configuration and aclosed configuration in response to a closure motion by the closuredriver, wherein the first jaw and the second jaw cooperate to grasptissue in the closed configuration, and wherein the staple cartridgecomprises: staples deployable from the staple cartridge into the tissue,wherein each of the staples comprises: a central portion; a first legextending from the central portion; and a second leg extending from thecentral portion, wherein the first cup comprises a first surface shapedto bend the first leg toward a first side of the central portion, andwherein the second cup comprises a second surface shaped to bend thesecond leg toward a second side of the central portion opposite thefirst side; and a sled movable to deploy the staples into the tissue,wherein the sled comprises a camming surface movable into a directengagement with the central portion to motivate the first leg to contactthe first surface of the first cup and the second leg to contact thesecond surface of the second cup.
 16. The end effector of claim 15,wherein the first leg comprises a first end, wherein the second legcomprises a second end, and wherein the first end is deformed in a firstdirection, and wherein the second end is deformed in a second directiontransverse to the first direction.
 17. The end effector of claim 16,wherein an angle is defined between the first direction and the seconddirection, and wherein the angle is between approximately 0.1 degreesand approximately 90 degrees.
 18. The end effector of claim 15, whereinthe first cup comprises a first inner surface at least partiallypositioned on a first side of the longitudinal axis, and wherein thesecond cup comprises a second inner surface at least partiallypositioned on a second side of the longitudinal axis.
 19. The endeffector of claim 18, wherein the first inner surface defines a firstplane oriented at an angle with respect to the longitudinal axis, andwherein the second inner surface defines a second plane oriented at anangle with respect to the longitudinal axis.
 20. The end effector ofclaim 18, wherein the first cup and the second cup are separated by asidewall, wherein a first side of the sidewall comprises the first innersurface, and wherein a second side of the sidewall comprises the secondinner surface.